CLEAR IVH: Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage (IVH)

Not Applicable

Completed

• Conditions: Intraventricular hemorrhage; Circulatory System

• Registration Number: ISRCTN47341677
• Lead Sponsor: Johns Hopkins University (USA)

Brief Summary

1. 2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21940973 (added 11/04/2019) 2. 2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22382155 (added 11/04/2019) 3. 2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22474059 (added 11/04/2019) 4. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23370203 (added 11/04/2019) 5. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23463422 (added 11/04/2019) 6. 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26228884 (added 11/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-09-23
• Study Completion: 2007-04-30
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 64

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. 30-day mortality<br> 2. Incidence of ventriculitis, meningitis<br> 3. Rate of bleeding events<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Rate of clot size reduction at Days 4-5 determined by CT scans (stages 1 and 2)<br> 2. 90 & 180 day GOS, Rankin, Stroke Impact Scale (stage 2 only)<br>