(Stroke. 1997;28:1530-1540.)
© 1997 American Heart Association, Inc.
Articles |
A Systems Approach to Immediate Evaluation and Management of Hyperacute Stroke
Experience at Eight Centers and Implications for Community Practice and Patient Care
Correspondence to Steven R. Levine, MD, Center for Stroke Research, Department of Neurology (K-11), Henry Ford Hospital and Health Science Center, 2799 W Grand Blvd, Detroit, MI 48202-2689. E-mail stevel{at}neuro.hfh.edu
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Abstract |
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Background and Purpose With the approval by the Food and Drug Administration of recombinant tissue plasminogen activator (rt-PA) for acute ischemic stroke within 180 minutes of symptom onset, patients and prehospital and hospital systems will now have to treat stroke as a medical emergency. It is thus critical to develop efficient hospital-based methods for hyperacute stroke patient evaluation and intervention at both community-based and tertiary care academic centers.
Methods We describe how the eight centers in the National Institute of Neurological Disorders and Stroke rt-PA Stroke Trial developed systems for enrolling patients within 3 hours of symptom onset. The actual methodology and practical sequence of events are detailed. Deming principles of system organization were applied, and each center developed a flowchart of acute stroke patient screening, assessment, and treatment. We divided the process into the following: clinical center background and preparation, screening, stroke team response, data needed before treatment, CT of the head, pharmacy, patient treatment, and monitored care. Critical features, both unique to a given center and shared by several centers (common at four or more centers), were summarized.
Results Phase I of the trial included several months of preparation with review of every detail involved in the process of acute stroke care at each site. All centers worked closely with emergency medical services. Community stroke awareness and education programs were developed. A stroke team was initiated and worked closely with the emergency department physicians and nurses. Rapid and efficient communication systems and protocols were established to reduce time to complete each task. Standardized stroke examinations and protocols for blood pressure management and intracranial hemorrhage detection as well as nursing flowcharts were used.
Conclusions Hyperacute stroke treatment can be initiated, often within 55 minutes of patient arrival at the hospital, in both community and academic settings when all aspects of stroke care processes are identified, streamlined, and built into the day-to-day operations of the prehospital and hospital healthcare delivery system.
Key Words: cerebrovascular disorders • emergency medical services • stroke, acute • plasminogen activator, tissue-type • thrombolytic therapy
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Introduction |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix IReferences |
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Recent data support the benefit of intravenous rt-PA given within 3 hours of ictus in ischemic stroke.1 The most common reason for exclusion in this stroke treatment protocol and other promising paradigms is delay in presentation.2 3 4 5 6 7 8 9 10 Both emergency medical systems and community education can dramatically reduce the time from stroke onset to hospital arrival and triage.4 11 12 It is thus critical to develop efficient hospital-based methods for hyperacute stroke patient screening, evaluation, and intervention at both community-based and tertiary care academic centers since hyperacute stroke is now a medical emergency.
We describe how the eight centers (see "Appendix I") in the NINDS rt-PA Stroke Trial developed systems for enrolling patients into a thrombolysis trial within 3 hours of stroke onset. The actual "nuts and bolts" methodology required to implement this type of care is presented. We outline the practical sequence of events necessary from stroke onset to treatment initiation and subsequent monitoring. Each site at the eight centers is included. The goal of this communication is to provide a variety of models and details of how patients were treated in the NINDS rt-PA Stroke Trial within 180 minutes of symptom onset so that health systems interested in developing acute stroke treatment protocols may focus on the methodology of the site most similar to their own.
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Methods |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix IReferences |
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The NINDS rt-PA Stroke Trial was initiated to test the activity and efficacy (robust, long-term functional and neurological improvement) of acute intravenous thrombolytic therapy in patients with acute ischemic stroke.1 Patients were identified and treated within two balanced time strata: 0 to 90 minutes and 91 to 180 minutes after symptom onset.1 During the preenrollment phase of the trial, Deming principles of system organization were applied, and each center developed a flowchart of acute stroke patient screening, assessment, and treatment.13 The Deming principles include the need to understand each process, the causes of variation in each process, and the involvement of the people carrying out the process to improve the process. The flowcharts were modified as the trial progressed and as clinical centers improved their systems. Flowcharts from each center were collected and analyzed. We divided the process into the following: clinical center background and preparation, screening, stroke team response, data needed before treatment, CT scanning, pharmacy support, patient treatment, and monitored care. Stroke teams were developed to provide this investigational therapy without disrupting usual patient care activities, ie, we could not ask others to do our research while they were caring for usual patients.
Each center (see "Appendix I") was sent an outline with these headings to provide further operational details. Results were collated, and critical features, both unique to a given center and shared by several centers, were summarized. We arbitrarily defined common system structures as those features that were present in four or more centers. The goal was to treat patients within 55 minutes of patient arrival at the hospital. We also asked the centers to summarize the most important lessons learned from the trial.
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Results |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix IReferences |
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The common system structures among the eight centers are summarized in the text. The systems created for acute stroke care were multidisciplinary teams that linked the following: community education regarding the use of 911, rapid response by EMS, rapid stroke team response, access to rapid CT scanning, laboratory studies, and treatment and hospital resources for monitored care. The centers are further characterized in Table 1
. The
unique features of each center/site are compared and summarized in
Tables 2 through 4.
Table 2 compares features among university centers with multiple
hospital sites and central (university) control of EMS. Table 3
compares unique characteristics of systems associated with single
site/community academic hospitals. Features of university hospital
centers with single or no affiliated sites or multiple sites but no
central control (ie, independent) of EMS are summarized in Table 4.
Four hundred of the 624 patients (64%) were evaluated and treated from
centers with six or more hospitals.
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Organization of the Stroke Team
The on-call stroke team generally consisted of the principal
investigator, co–principal investigators, physician investigators, and
study/recruitment coordinator(s).
Clinical Center Background and Preparation Before Enrollment
(Treatment) of Patients
Phase 1 of the NINDS rt-PA Stroke Trial included several months of
preparation before patient recruitment. During this preparatory phase,
flowcharting of current processes with the use of total quality
improvement methods13 was performed for stroke patients
admitted to the ED. The total quality improvement method scrutinizes
the process of an activity rather than the people performing that
activity and uses the people involved in the process to improve the
process (ie, to reduce the time and variability for a given process).
Any process that had an impact on patient enrollment into the
trial13 was analyzed by flowcharting. Several
centers had experience with clinical stroke trials, including stroke
registries, while others did not. Two centers were already recruiting
patients within 3 hours of stroke into treatment trials.14
At all centers a relationship with EMS was initiated or reinforced, and
EMS was informed of the protocol. Some centers taught paramedics how to
prescreen ("quick screen") patients. Guidelines for
ambulance/field-based hyperacute stroke patient quick screening
included the following: (1) signs and symptoms consistent with
an acute stroke (eg, acute focal neurological deficit: gaze deviation,
altered speech/language, unilateral weakness, gait instability); (2)
age over 18 years; and (3) stroke onset within a predefined number of
hours. Inservices and continuing medical education programs were
specifically directed toward rapid identification of stroke signs and
symptoms and management in the field by EMTs. Each center focused on
creating a permanent, rapid, and effective linkage with EMS. Efforts
were made to have EMS deal with stroke at a higher level priority than
was standard, ie, generally no lights and sirens and the third highest
priority. (Lights and sirens were generally reserved for trauma and
cardiorespiratory compromise.)
Community hospitals were evaluated by the local principal investigator and nurse coordinator(s) for their ability to respond rapidly. The stroke team worked closely and regularly with ED physicians and nurses. The nurse coordinators taught ED, laboratory, radiology, and other staff at each hospital about the protocol and developed a communication system to contact on-call physicians and nurses emergently for any patient with acute stroke. Five centers had dedicated beepers, and all eight centers used cellular phones for the physicians and nurses to facilitate a rapid access communication system. An on-call schedule for the stroke team was developed.
Recruitment coordinators developed community awareness programs about stroke risk factors and warning signs and emphasized that stroke is a "911" emergency condition. Treating physicians (n=68 for part 1) and some nurses were certified to perform the NIHSS.15 Most certified physicians practiced in nonuniversity settings.
Screening Procedures and Triage
All centers developed either hospital-based or
ambulance/field-based screening procedures. Screening was performed
according to the inclusion/exclusion guidelines from the NINDS rt-PA
Stroke Trial.1 To speed patient triage, the paramedics
were trained at some sites to contact the base station while still in
the field regarding the probability of stroke and the time of onset.
The base station then activated the stroke team before the
arrival of the patient, enabling the Stroke Team to meet the patient at
the ED. During the trial, 17 324 patients were screened over 46 months
to treat 624 patients.
An ED or triage nurse performed laboratory studies, obtained baseline vital signs, and started an intravenous line (0.45 or 0.9 normal saline) and also a capped intravenous line within 5 to 10 minutes of the patient's arrival. Head CT scanning of a potentially eligible patient was performed immediately thereafter. The focus was on efficiency of patient flow, with emphasis on inclusion criteria (to maximize sensitivity) to save time and capture every possible patient. The use of mobile communications by the on-call stroke team expedited contacts of the stroke team physicians with primary care physicians, ED, laboratory, CT suite, and pharmacy and ensured completion of many tasks before the stroke team physician's arrival at the ED, including all required blood tests, ECGs, and fingerstick glucose tests.
After the completion of the trial and publication of the results, an
effort was made to standardize standing orders in the ED for evaluation
of potential rt-PA candidates and further standing orders once a
decision was made for treatment with rt-PA (Figs 1 through 3 and Table 5 in Appendix
II).
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Stroke Team Response
A single beeper number ("Stroke Hotline") for the stroke team
was frequently used. With one exception, the stroke team was available
24 hours a day, 7 days a week. The ED physician performed a general
patient evaluation. The stroke team performed a final screening for
eligibility, explained potential risks and benefits (obtained informed
consent during the trial), and assessed the patient with the requisite
stroke scales. If only slightly above the exclusion range, blood
pressure was treated with small doses of labetalol or
nitroglycerin paste (see Table 5
, section 6, in
"Appendix II"). No aggressive measures to reduce blood pressure
were used before treatment.
Data Needed Before Treatment
The stroke team physician established the exact time of
stroke onset or determined the last time the patient was observed
without a new neurological deficit. Blood was drawn in the ED for CBC,
platelet count, PT, PTT, glucose, electrolytes, and renal function
studies. Blood samples were taken by predetermined arrangement (at
times hand carried) to the appropriate laboratory, and tests were
performed as soon as possible. Test results were either telephoned to a
treating physician, or a member of the stroke team called the
laboratory for results. Results of the laboratory studies were known in
approximately 20 to 30 minutes. The longest processing time was for the
PT, which is only needed before treatment in patients with possible use
of anticoagulation therapy. PTT was only needed before treatment if the
patient received heparin during the previous 48 hours.
Some centers could obtain permission to treat by telephone from family members. The stroke team physician reviewed head CT scan results and performed the NIHSS. The patient's weight was estimated for determination of drug dosages.
CT Scanning
The baseline CT was performed to exclude intracranial
hemorrhage, other mass lesion, or midline shift. The on-call CT
technician was notified by the stroke team or ED by telephone/pager as
early as possible. The CT technicians considered stroke a "stat"
priority. CT technicians were generally in-house or available within 20
minutes (occasionally up to 45 minutes), 24 hours a day, 7 days a week
(sometimes with the exception of a few shifts per week). To enhance
speed of acquiring the pretreatment CT, 10-mm cuts were used and no
contrast was given. CT technicians were regularly updated about the
protocol to enhance response time.
The CT was often read off the console rather than waiting for "hard" copies before treatment. The stroke team physician read the CT scan before treatment and generally did not wait for a radiologist's interpretation unless there was a question that might affect drug administration. The time from start of CT scan to reading images off the monitor could be as short as 6 to 7 minutes, depending on the make and model of the CT scanner. Since time from symptom onset was an exclusion, evidence of mass effect or edema triggered a reevaluation of the exact time of stroke onset, although patients with these CT findings were included and treated.
Pharmacy
Drugs were either stored in the pharmacy (the ED pharmacy) or kept
in a locked cabinet in the ED. Pharmacies were notified of potential
candidates as early as possible. This allowed time for drug and
materials to be obtained and set out before they were mixed. The
pharmacies were then recontacted to mix the drug if the patient was a
candidate. An intravenous flush after study drug infusion
ensured complete delivery of a full dose. The drug was often mixed and
available by the time the CT was performed and read. A pharmacist mixed
the drug at five centers, and the principal investigator or coordinator
performed this task at the other three centers. It took several minutes
(up to 10 minutes) to have the drug reconstituted and delivered to the
treatment area. If mixed drug is not administered (outside of a
research study), it can be returned to the manufacturer for credit.
Patient Treatment
Treatment was initiated as soon as possible after the CT scan was
reviewed and inclusion and exclusion criteria were met (including
informed consent). Blood pressure was checked just before treatment, as
were any signs of rapid improvement. Treatment began in the CT suite
for many patients. The treating physician administered the
intravenous bolus over 1 minute and began the 60-minute
intravenous infusion. The patient was transferred back to
the ED or ICU while the intravenous infusion was running.
Assessments were performed every 15 minutes during treatment.
Monitored Care
The first 24-hour period of monitoring occurred in an ICU or ASU
setting with 1:1 or 1:2 nursing ratios. If an intracranial
hemorrhage was suspected, a standardized assessment was
performed (Fig 4 in "Appendix
II"). In general, the ICU or ASU
nurses completed the neurological and vital sign assessment flow sheets
(Fig 5 in "Appendix II"). A
flowchart protocol was strictly followed to ensure proper monitoring of
neurological status, cardinal signs, evidence of external bleeding, and
vital signs. The practical purpose of assessing motor strength at 15 to
30 minutes after administration of drug bolus is to determine whether
there is neurological worsening or improvement. We have seen both cases
at this early point, and worsening could indicate a
symptomatic intracranial hemorrhage. The 2-hour
neurological assessment was completed by the treating stroke team
physician or nurse certified in the NIHSS. Blood pressure was monitored
and treated by a specific protocol (Table 5, section 6, in "Appendix
II").
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Specific Lessons Learned by the Eight Centers
Following is a summary of specific lessons identified as the most
important in the different systems. These highlights were critical to
the success of individual centers or seen as helpful in their center.
The most critical aspects of rapid response to stroke were continued
contact with and education of paramedics and ED nurses/physicians and
coordination of laboratory, CT, and pharmacy services (Emory University
School of Medicine, Atlanta, Ga). Community education was essential in
shortening patients' response time to seeking medical attention for
stroke. Nursing standards for stroke needed updating in both the ED and
the ASU, specifically in regard to ratios of patients to nurses (Henry
Ford Hospital and Health Sciences Center, Detroit, Mich). There was a
need to establish a personal relationship with specific support service
personnel (eg, laboratory) to enhance the efficiency of the protocol
(Long Island Jewish Medical Center, Queens, NY). As emergency stroke
care requires EMS education, reviews and discussions of audiotapes of
actual runs were included on a monthly basis. A videotape on basic
stroke concepts was distributed to all fire stations for Continuing
Medical Education credits for the EMTs (University of California at San
Diego). False alarms were used as an opportunity to promote acute
stroke treatment and reinforce protocols. Current "code blue"
mechanisms within each hospital were used as the basis for acute stroke
team activation rather than developing new systems specific to stroke.
Urgent stroke evaluation and treatment are of low frequency but high
complexity, even at the busiest stroke centers. Any one individual (eg,
ED physician) or team (eg, ED nurses) may be directly involved so
infrequently that nonrepeated messages are forgotten (University of
Cincinnati). CT scanners were used to make a rapid high-quality
anteroposterior chest x-ray film to promote rapid evaluations
(University of Tennessee). Cheerful and prompt response to all
EMS/triage nurse calls regarding a potential patient for treatment was
necessary because the treatment protocol can be intense, stressful, and
tiring. EMS should be fully integrated into the stroke team and provide
regular positive feedback and patient progress reports (University of
Texas Medical School, Houston). The stroke team handled
"exclusions" carefully: Every acute stroke patient received
"urgent" care, despite study eligibility (University of Virginia
Health Sciences Center, Charlottesville).
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Discussion |
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Before the initiation of the NINDS rt-PA Stroke Trial,1 all eight clinical centers had been involved in acute stroke trials. However, "acute" was variously defined from 90 minutes to 48 hours of symptom onset.16 17 Some centers had already developed systems for hyperacute protocols4 11 14 17 18 to treat patients within 90 minutes to 6 hours after symptom onset. This trial was the first impetus for several centers to develop and refine their hyperacute stroke treatment systems. Clearly, implementation of these systems was a major reason for the greater than expected patient recruitment rate in the trial.
Certain key features are necessary before initiation of such a program. Specific implementation of some features may depend on factors intrinsic to the hospital, such as teaching status and university affiliation. Most of the patients were enrolled at nonuniversity hospitals, suggesting that house officers are not essential for creation of a stroke treatment system.
To shorten the time from ED arrival to treatment of a stroke patient, it is critically important to have a working understanding of one's own system of patient evaluation and treatment. We found that flowcharting13 a given system highlighted processes that could be improved and indicated points where stroke protocols could be intercalated into existing methods. Flowcharts facilitated discussions among members of several diverse clinical departments, focusing the discussants on problems in the process and away from blaming individuals from other departments.
Common Lessons Learned Among the Eight Centers
For acute stroke patients to be enrolled in hyperacute treatment
protocols, all aspects of the process from patient identification to
discharge must be initially evaluated, streamlined, and built into the
day-to-day operations of the prehospital and hospital healthcare
systems. System design should be focused on efficiency of patient care
to save every possible minute. Regular training and retraining for all
involved personnel were necessary in both the short term and long term.
Having a CT scanner in or immediately adjacent to the ED and a
prenotified in-house technician saves considerable time. Team members
who work to identify patients and expedite care are praised and
encouraged for their efforts. EMS education was critical for success.
EMS transport of a family member with the patient is invaluable to
obtain an accurate history for time of onset and consent. Practicing
patient enrollment sessions (drills) points out hidden obstacles and
keeps the team well poised. Review of the entire system and experience
on a regular basis (every 1 to 3 months) is probably a key feature of
improvement and consistency.
Implications for Stroke Care
Based on the results of the NINDS rt-PA Stroke
Trial,1 there are many imperatives for health system
improvements in the prehospital and hospital care of acute stroke
patients. Major efforts will be needed to educate EMS about emergency
recognition and management of stroke. The priority level for stroke
will need to be modified to handle stroke as the highest priority
("lights and sirens"). This will involve local EMS Medical
Directors or Medical Control Boards changing the priority of stroke
based on the available data from this trial. If local politics or
competition causes delays in progress, discussions with city or
municipal governances or councils that fund EMS may be necessary.
EMS should establish radio contact with EDs and may establish intravenous lines, determine fingerstick glucose levels, and assess stroke severity. Furthermore, EDs must also provide rapid triage and evaluation of all acute stroke patients. Acute stroke is a 911 emergency that will require expedited care and treatment at every level of the health delivery system.
Collaborative efforts among emergency physicians, neurologists, radiologists, and clinical laboratories are needed for each system to provide rapid stroke treatment. In the majority of centers, a neurologist had primary responsibility for protocol and policies. However, an ED physician at one site had primary responsibility for the stroke team. Telemedicine, including digital image transfer for CT viewing, may provide the needed "face-to-face" contact for neurologists in their offices or homes if they are not able to get to the hospital quickly. However, the efficacy of this method is unproven. Neurologists or neurosurgeons could assist emergency physicians through the treatment protocol by providing accurate reading of the head CT scans (as could radiologists) and additional stroke assessment. Alternatively, acute stroke teams could be formed, all skilled in using the NIHSS (or other optimally standardized stroke assessment tool) and the interpretation of hyperacute stroke head CT images. Compact disk interactives could be used to instruct physicians in real time on the protocol, including stroke scales and head CT review.
The data also suggest that the window for effective ischemic stroke treatment may be only a few hours,19 and therefore "acute brain protocols" within EDs may facilitate minimizing time from patient arrival in the ED to treatment.
The overall goal is to treat strokes during the window of opportunity when therapy can be effective.20 No matter how streamlined the prehospital and hospital care is, little can be done if patients do not present until late in the event. The University of California at San Diego captured only 1% of the estimated number of strokes, despite efforts at EMS, nurse, and physician education, in combination with smooth hospital system organization.4 Therefore, the next critical step is patient/community education, so that the public can recognize the signs and symptoms of stroke and activate the emergency system.10 21 22 Such education must be widespread and repetitive and could be supported by national voluntary health organizations (eg, American Medical Association, National Stroke Association, American Heart Association).23
As multiple studies have demonstrated, the positive effect of professional and public education on both reducing time to arrival to EDs for acute stroke patients and increasing recognition of stroke symptoms will mandate that hospitals, health systems, HMOs, and departments of neurology and neurosurgery establish stroke education program coordinators—positions that are probably cost-effective in the long term, given the reduction in stroke burden that effective treatment can provide. Better patient outcomes with early treatment should result in shorter, less expensive hospital stays and a decrease in disability payments.24 25
The cost of creating a system for immediate evaluation and management of hyperacute stroke should be minimal and will be offset in the long term by the cost savings of using t-PA in the greatest number of eligible patients.25 The short-term costs emphasize the need to create a simple and easily applied system. Costs can be contained by adapting current acute care systems and perhaps identifying existing hospital-paid personnel to be involved until this method becomes routine.
In summary, we attempt to provide information on the methods used to treat acute stroke patients within a time window that has been shown to allow efficacy of t-PA. This information should provide practical information that will supplement recently published guidelines on thrombolytic therapy for stroke.26 We also strive to allow more hospitals to contribute in this area, eventually leading to a greater number of treated patients.
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Selected Abbreviations and Acronyms |
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Acknowledgments |
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This study was supported by NINDS/NIH (NO1-NS-02382, NO1-NS-02374, NO1-NS-02377, NO1-NS-02381, NO1-NS-02379, NO1-NS-02373, NO1-NS-02378, NO1-NS-02376, and NO1-NS-02380).
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Footnotes |
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A complete list of the participants in this research study appears at the end of this article.
Some of the NINDS rt-PA investigators are on the Genentech speaker's list.
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Appendix I |
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TopAbstractIntroductionMethodsResultsDiscussionAppendix IReferences |
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The following persons and institutions participated in the NINDS rt-PA Stroke Trial.
Clinical Centers: University of Cincinnati (150 patients): Principal Investigator: T. Brott; Coinvestigators: J. Broderick, R. Kothari, M. O'Donoghue, W. Barsan, T. Tomsick; Study Coordinators: J. Spilker, R. Miller, L. Sauerbeck; Affiliated Sites: St Elizabeth (South): J. Farrell, J. Kelly, T. Perkins, R. Miller; University Hospital: T. McDonald; Bethesda North Hospital: M. Rorick, C. Hickey; St Luke (East): J. Armitage, C. Perry; Providence: K. Thalinger, R. Rhude; The Christ Hospital: J. Armitage, J. Schill; St Luke (West): P.S. Becker, R.S. Heath, D. Adams; Good Samaritan Hospital: R. Reed, M. Klei; St Francis/St George: A. Hughes, R. Rhude; Bethesda Oak: J. Anthony, D. Baudendistel; St Elizabeth (North): C. Zadicoff, R. Miller; St. Luke–Kansas City: M. Rymer, I. Bettinger, P. Laubinger; Jewish Hospital: M. Schmerler, G. Meiros.
University of California, San Diego (146 patients):Principal Investigator: P. Lyden; Coinvestigators: J. Dunford, J. Zivin; Study Coordinators: K. Rapp, T. Babcock, P. Daum, D. Persona; Affiliated Sites: University of California, San Diego: M. Brody, C. Jackson, S. Lewis, J. Liss, Z. Mahdavi, J. Rothrock, T. Tom, R. Zweifler; Sharp Memorial: R. Kobayashi, J. Kunin, J. Licht, R. Rowen, D. Stein; Mercy Hospital: J. Grisolia, F. Martin; Scripps Memorial: E. Chaplin, N. Kaplitz, J. Nelson, A. Neuren, D. Silver; Tri-City Medical Center: T. Chippendale, E. Diamond, M. Lobatz, D. Murphy, D. Rosenberg, T. Ruel, M. Sadoff, J. Schim, J. Schleimer; Mercy General, Sacramento: R. Atkinson, D. Wentworth, R. Cummings, R. Frink, P. Heublein.
University of Texas Medical School, Houston (104 patients): Principal Investigator: J.C. Grotta; Coin-vestigators: T. DeGraba, M. Fisher, A. Ramirez, S. Hanson, L. Morgenstern, C. Sills, W. Pasteur, F. Yatsu, K. Andrews, C. Villar-Cordova, P. Pepe; Study Coordinators: P. Bratina, L. Greenberg, S. Rozek, K. Simmons; Affiliated Sites: Hermann Hospital, St Luke's Episcopal Hospital, Lyndon Baines Johnson General Hospital, Memorial Northwest Hospital, Memorial Southwest Hospital, Heights Hospital, Park Plaza Hospital, Twelve Oaks Hospital.
Long Island Jewish Medical Center (72 patients):Principal Investigators: T.G. Kwiatkowski (6/92-), S.H. Horowitz (12/90-5/92); Coinvestigators: R. Libman, R. Kanner, R. Silverman, J. LaMantia, C. Mealie, R. Duarte; Study Coordinators: R. Donnarumma, M. Okola, V. Cullin, E. Mitchell.
Henry Ford Hospital (62 patients):Principal Investigator: S.R. Levine; Coinvestigators: C.A. Lewandowski, G. Tokarski, N.M. Ramadan, P. Mitsias, M. Gorman, B. Zarowitz, J. Kokkinos, J. Dayno, P. Verro, C. Gymnopoulos, R. Dafer, L. D'Olhaberriague; Study Coordinators: K. Sawaya, S. Daley, M. Mitchell.
Emory University School of Medicine (39 patients):Principal Investigator: M. Frankel (7/92-10/95), B. Mackay (11/90-6/92); Coinvestigators: J. Weissman, J. Washington, B. Nguyen, A. Cook, H. Karp, M. Williams, T. Williamson; Study Coordinators: C. Barch, J. Braimah, B. Faherty, J. MacDonald, S. Sailor; Affiliated Sites: Grady Memorial Hospital, Crawford Long Hospital, Emory University Hospital, South Fulton Hospital: M. Kozinn, L. Hellwick.
University of Virginia Health Sciences Center (37 patients): Principal Investigator: E.C. Haley, Jr; Coinvestigators: T.P. Bleck, W.S. Cail, G.H. Lindbeck, M.A. Granner, S.S. Wolf, M.W. Gwynn, R.W. Mettetal, Jr, C.W.J. Chang, N.J. Solenski, D.G. Brock, G.F. Ford; Study Coordinators: G.L. Kongable, K.N. Parks, S.S. Wilkinson, M.K. Davis; Affiliated Sites: Winchester Medical Center: G.L. Sheppard, D.W. Zontine, K.H. Gustin, N.M. Crowe, S.L. Massey.
University of Tennessee (14 patients):Principal Investigator: M. Meyer (2/93-), K. Gaines (11/90-1/93); Study Coordinators: A. Payne, C. Bales, J. Malcolm, R. Barlow, M. Wilson; Affiliated Sites: Baptist Memorial Hospital: C. Cape; Methodist Hospital Central: T. Bertorini; Jackson Madison County General Hospital: K. Misulis; University of Tennessee Medical Center: W. Paulsen, D. Shepard.
Coordinating Center: Henry Ford Health Sciences Center: Principal Investigator: B.C. Tilley; Coinvestigators: K.M.A. Welch, S.C. Fagan, M. Lu, S. Patel, E. Masha, J. Verter; Study Coordinators: J. Boura, J. Main, L. Gordon; Programmers: N. Maddy, T. Chociemski; CT Reading Centers: Part A—Henry Ford Health Sciences Center: J. Windham, H. Soltanian Zadeh; Part B—University of Virginia Medical Center: W. Alves, M.F. Keller, J.R. Wenzel; Central Laboratory: Henry Ford Hospital: N. Raman, L. Cantwell; Drug Distribution Center: A. Warren, K. Smith, E. Bailey.
National Institute of Neurological Disorders and Stroke: Project Officer: J.R. Marler.
Data and Safety Monitoring Committee: J.D. Easton, J.F. Hallenbeck, G. Lan, J.D. Marsh, M.D. Walker.
Genentech Participants: Juergen Froelich, Judy Breed, Fong Wang-Chow.
Received March 4, 1997; revision received May 5, 1997; accepted May 5, 1997.
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References |
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