Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage Phase III
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Jacksonville, Florida: 09-002525
NCT ID: NCT00784134
Sponsor Protocol Number: IVH06
About this study
The overall objective of this Phase III clinical trial is to obtain information from a population of 500 ICH subjects with intraventricular hemorrhage (IVH), representative of current clinical practice and national demographics of ICH regarding the benefit (or lack thereof) of IVH clot removal on subject function as measured by modified Rankin Scale (mRS). This application requests funding for five years to initiate a Phase III randomized clinical trial (RCT) testing the benefit of clot removal for intraventricular hemorrhage. The investigators propose to compare extraventricular drainage (EVD) use plus recombinant tissue plasminogen activator (rt-PA; Alteplase; Genentech, Inc., San Francisco, CA and Boehringer Ingelheim, Inc., Ingelheim, Germany) with EVD+ placebo in the management and treatment of subjects with small intracerebral hemorrhage (ICH) and large intraventricular hemorrhage (IVH defined as ICH < 30 cc and obstruction of the 3rd or 4th ventricles by intraventricular blood clot).
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility 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
- 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
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
William Freeman, M.D.
Closed for enrollment