Intrathecal clot lysis trial to reduce vasospasm in aneurysmal subarachnoid hemorrhage for better outcomes.
- Conditions
- Health Condition 1: G973- Intraoperative hemorrhage and hematoma of a nervous system organ or structure complicating a procedure
- Registration Number
- CTRI/2022/11/047665
- Lead Sponsor
- JIPMER PUDUCHERRY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Patients who are diagnosed with subarachnoid hemorrhage due to an aneurysmal rupture diagnosed with appropriate imaging methods like CT scan, CT angiography, MRI, MR angiography, and Digital Subtraction Angiography (DSA) and who have undergone treatment of the ruptured aneurysm, typically by microsurgical clipping or coiling.
Remote subarachnoid hemorrhage (more than 14 days of aneurysmal rupture) where either the vasospasm has already set in or is likely to have disappeared.
Patients who have already developed severe vasospasm (Mean velocities of the MCA of 200 cm/sec or greater indicate severe spasm and correlate with 50% or greater narrowing on angiogram) detected by any imaging method or have already suffered delayed neurological deficits.
Patients in whom the ruptured aneurysm could not be fully secured by microsurgical clipping or endovascular coiling.
Spontaneously thrombosed aneurysms will also be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To see if intrathecal clot lysis by instilling a thrombolytic agent reduces the mortality in patients with aneurysmal subarachnoid hemorrhage compared to a placeboTimepoint: During hospital stay and at discharge
- Secondary Outcome Measures
Name Time Method Glasgow Outcome Scale (GOS) by classifying death, persistent vegetative state, and severe disability as bad outcomes and moderate disability and low disability as a good outcomes at the time of discharge from the hospital. <br/ ><br>Timepoint: at the time of discharge from the hospital. <br/ ><br>