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| [ ...Back to search results ] | [ Print-friendly version ] |
| CLEAR IVH: Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (IVH) |
| ISRCTN | ISRCTN47341677 |
| ClinicalTrials.gov identifier | |
| Public title | CLEAR IVH: Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (IVH) |
| Scientific title | |
| Acronym | CLEAR IVH |
| Serial number at source | 8523-072004 |
| Study hypothesis | The specific objective of this trial is to determine the lowest dose possible with the best pharmacokinetic and safety profile and its ability to remove blood clot from the ventricular system |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | United States of America |
| Disease/condition/study domain | Intraventricular hemorrhage |
| Participants - inclusion criteria |
1. Age 18-75
2. Intraventricular catheter (IVC) placed as standard of care using less than or equal to two complete passes 3. Spontaneous intracerebral hemorrhage (ICH) <30 cc 4. Able to receive first dose within 48 hours of computed tomography (CT) scan diagnosing IVH (providing the time of symptom onset to diagnostic CT does not exceed 12 hours) 5. Clot size measured on CT scan done 6 hours after IVC placement must be equal to the presentation clot size + 5 cc (as determined by the (A x B x C)/2 method) 6. On stability CT scan either the 3rd or 4th ventricles are occluded with blood (no evidence of cerebrospinal fluid [CSF] flow on CT) 7. Systolic blood pressure (SBP) <200 mmHg sustained for 6 hours 8. Historical Rankin of 0 or 1 |
| Participants - exclusion criteria |
1. Suspected or untreated aneurysm or arterio venous malformation (AVM) (unless ruled out by angiogram or magnetic resonance angiography [MRA]/magnetic resonance imaging [MRI])
2. Clotting disorders 3. Patients with platelet count <100,000, international normalized ratio (INR) >1.7, prothrombin time (PT) >15 s, or an elevated activated partial thromboplastin time (APTT) 4. Pregnancy (positive pregnancy test) 5. Infratentorial hemorrhage (i.e. parenchymal/posterior fossa hematoma; all cerebellar hematomas are excluded) 6. Subarachnoid hemorrhage (SAH). (An angiogram should be obtained when the diagnostic CT scan demonstrates subarachnoid hemorrhage or any hematoma location or appearance not strongly associated with hypertension. If the angiogram does not demonstrate a bleeding source that accounts for the hemorrhage, the patient is eligible for the study.) 7. ICH enlargement during the 6-hour stabilization period (6 hours after IVC placement) 8. Internal bleeding, involving retroperitoneal sites, or the gastrointestinal, genitourinary, or respiratory tracts 9. Superficial or surface bleeding, observed mainly at vascular puncture and access sites (e.g. venous cutdowns, arterial punctures) or site of recent surgical intervention 10. Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, and subacute bacterial endocarditis 11. Prior enrollment in the study 12. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated 13. Participation in another simultaneous medical investigation or trial |
| Anticipated start date | 01/02/2004 |
| Anticipated end date | 30/04/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | Stage 1 complete (n = 16); Stage 2 open (n = 36-48) |
| Interventions |
Stage 1: patients received intraventricular injections of either 0.3 mg or 1.0 mg of rt-PA every 12 hours for up to eight doses
Stage 2: patients will receive 1.0 mg every 8, 6, or 4 hours depending on the dose tier open at the time of enrollment |
| Primary outcome measure(s) |
1. 30-day mortality
2. Incidence of ventriculitis, meningitis 3. Rate of bleeding events |
| Secondary outcome measure(s) |
1. Rate of clot size reduction at Days 4-5 determined by CT scans (stages 1 and 2)
2. 90 & 180 day GOS, Rankin, Stroke Impact Scale (stage 2 only) |
| Sources of funding | FDA Office of Orphan Products Development and Genentech, Inc. |
| Trial website | http://www.neuro.jhmi.edu/ivh |
| Publications | |
| Contact name | Dr Daniel Hanley |
| Address |
600 N. Wolfe Street
Jefferson 1-109 |
| City/town | Baltimore, Maryland |
| Zip/Postcode | 21287 |
| Country | United States of America |
| Sponsor | Johns Hopkins University (USA) |
| Address |
600 N. Wolfe Street
Jefferson 1-109 |
| City/town | Baltimore, Maryland |
| Zip/Postcode | 21287 |
| Country | United States of America |
| Sponsor website: | http://www.neuro.jhmi.edu/ivh |
| Date applied | 16/07/2004 |
| Last edited | 19/02/2008 |
| Date ISRCTN assigned | 23/09/2004 |
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