Stroke
Current Protocols:
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Protocol: Abciximab (ReoPro® ) in Acute Ischemic Stroke: A Phase III, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Trial Status: Open
Principle Investigator: Jeffrey Hilburn
Sub Investigators: Charles Simchak, Caryn Vogel, Mark Janicki, Loretta VanEvery
Synopsis: Assess effectiveness of ReoPro on stroke outcomes for patients with Acute Stroke
Inclusion
- Patient has not been involved in any other drug / device study within the last 30 days
- Without suspicion of septic emboli
- Patient is without ICH symtomotology
- No ICH present per CT scan
- No presence of Thrombus in cerebral veins
- Hypodensity of MCA territory is < 50%
- No signs No other evidence of non-vascular cause of neurological symptoms of Mass effect causing shift of midline structures
- NIHSS Item 1a score is <2
- NIHSS Score is >3 and symptoms are not improving rapidly
- NIHSS Score is <22
- Platelet count is >100,000
- PTT<2 above upper normal range and INR <1.4
- No persistent Htn with SBP being >185 mmHg or DBP > 110mmHg.
- Actual Hx of Htm is
- No major hemorrhage in past 21 days
- No major surgery , serious trauma, lumbar puncture, arterial puncture at a non-Compressible site, or biopsy or parenchymal organ in last 14 days.
- No presumed or documented history or vasculitus
- No known systemic bleeding disorder
- There has been no intracranial surgery / head injury that required hospitalization or stroke within the past 3 months
- No ICH at any time in the past
- No intracranial neoplasm / AV malformation / intracranial aneurysm (aneurysm could be present if treated >3 months prior to this event)
- Pre stroke BI >95 and mRS <1
- Has not been treated with TPA (Ancrod) or intra-arterial thrombolytic for this stroke nor has had administration of intra-arterial or systemic thrombolytic in the last 7 days
- Has not had any unfractionated / low molecular weight heparin, direct thrombin inhibitor, Factor Xa inhibitor, or GPIIb/IIIa inhibitor within previous
- Will not be receiving any anti-coagulants / NSAIDS within the 1st 36 hours after receiving the study drug
- No allergy to Abciximab or other Murine proteins
- No need for major surgery within the next 72 hours
- No major trauma at time of stroke eg hip fracture
- Life expectance is expected to be >3 months
- No other serious illness or complex illness that may interfere with the treatment of this patient in the AbESTT II trial for example hepatic disease, cardiac disease, Renal disease, MI, AIDS, CA.
- Htn is presently under control (SBP<180 and DBP <105mmHg) without the use of Nitroprusside
Protocol: Neurobehavioral Outcome Trial of Stroke-Associated Depression (NOTSAD) a randomized, double-blind, placebo controlled study.
Trial Status: Plan to open Mid November
Principle Investigator: Jeffrey Hilburn
Synopsis: Patients treated with an antidepressant withing 5 days of acute stroke onset will show a decreased incidence of pst stroke depression(PSD) Duloxetine will be the anti-depressant used
Inclusion
- Individuals over 18 years of age with the diagnosis of acute ischemic stroke
- Symptom onset within 5 days of presentation to the hospital.
- Confirmed documented acute ischemic stroke per CT or MRI scan.
Exclusion
- Participation in another investigational trial or stroke treatment
- Severe aphasia or dementia making the patient incapable of participating in depression screens
- NIHSS < 3 or > 18
- Appearance of hemorrhage on initial CT scan
- History of mania
- History of antidepressant treatment at the time of stroke
- Evidence of liver failure or renal failure
- History of Seizures
- Confounding diagnosis giving reason to believe patient would not survive to complete the study.
- People who are allergic to duloxetine hydrochloride or the other ingredients in Cymbalta
- Patients taking thioridazine
- Patients who are taking or have taken MAOI in the past 6 months
- Patients with uncontrolled, narrow-angle glaucoma
Patients who receive TPA are NOT excluded from the NOTSAD study.
Protocol: CT FAST Cooperative Treatment for Acute Stroke Trial
Trial Status: Plan to open Mid December
Principle Investigator: Jeffrey Hilburn
Sub Investigator: Frank Pistoia
Synopsis: Patient having an acute stroke will have better outcomes if body temperature is decreased to 95 degrees Fahrenheit.
Inclusion:
- Age 18-80
- CT negative for ICH
- NIHSS > 4 < 25
- Must be able to initiate cooling procedure within 6 hours of symptom onset
Exclusion:
- Hx of CVA in previous 6 weeks
- Rapidly improving symptoms
- Sx suggestive of ICH despite CT scan being (-) for ICH
- Current Hx of sublingual NTG use > 1 x per day
- HX of renaudes syndrome
- EKG demonstrating acute ischemic changes
- Hx (per family / Physician report) of mental disease which would confound the neurological / functional evaluations.
- Serious or terminal illness
- Presence of Neoplasm
- Significant Mass effect with midline shift
- Presumed septic embolism or endocarditus
- Participation in another research study which would confound results of this or the other study.
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