Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT00784134
Eligibility Criteria:
Inclusion Criteria:
* Age 18-80
* 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 randomize 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 1.4
* Pregnancy
* Infratentorial hemorrhage
* SAH at clinical presentation
* 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
* Planned or simultaneous participation (between screening and Day-30) in another interventional medical investigation or clinical trial.
* No subject or legal representative to give written informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00784134
Study Brief:
Protocol Section:
NCT00784134