CLEAR III
Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
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Status:
This study is currently recruiting participants.
Purpose:
To determine whether rapid removal of IVH clot with low-dose rtPA more likely improves modified Rankin Scores at 6 months (Rankin 0-3) compared to subjects treated with best medical care alone.
Year Started:
2009
Design:
Interventional, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Efficacy Study, Parallel Assignment, Placebo Control, Randomized, Treatment.
Inclusion Criteria
Symptom onset less than 24 hrs prior to diagnostic CT scan;
Spontaneous ICH less than or equal to 30 cc or primary IVH;
IVH obstructing 3rd and/or 4th ventricles; ICH clot stability at 6 hours or more post IVC placement; IVH clot stability at 6 hours or more post IVC placement; Catheter tract bleeding stability 6 hours or more post IVC placement;
EVD placed per standard medical care; SBP less than 200 mmHg sustained for 6 hours prior to drug administration; able to receive first dose within 72 hours of diagnostic CT scan;
Historical Rankin of 0 or 1
Exclusion Criteria
Suspected or untreated ruptured cerebral aneurysm, AVM, or tumor; Presence of a choroid plexus vascular malformation or Moyamoya; clotting disorders; platelet count less than 100,000, INR greater than 1.7, or elevated PT or APTT; pregnancy; infratentorial hemorrhage (brainstem involvement or third nerve palsy); ICH/IVH enlargement that cannot be stabilized in the treatment time window; ongoing internal bleeding; superficial or surface bleeding prior enrollment in the study; any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
Patient Involvement:
Patient will have diagnostic CT scan first. Patient will have IVC placed. Modified Rankin Scale performed. Patients will be randomized to one of two arms witnin 72 hours of CT: in experimental arm patient will receive 1.0 mg of Cathflo Activase administered via the intraventricular catheter every 8 hours for up to 9 doses or to the control arm where the patient will receive 1 ml of normal saline administered via the intraventricular catheter every 8 hours for up to 9 doses
Primary Outcome:
Modified Rankin Scale.
Secondary Outcome:
All cause mortality; amount of residual blood; intensity of critical care management.
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Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 9/28/2009
Reviewed on: 03/30/2010.
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