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Intrathecal clot lysis trial to reduce vasospasm in aneurysmal subarachnoid hemorrhage for better outcomes.

Randomized placebo-controlled trial of intrathecal clot lysis to reduce vasospasm in aneurysmal subarachnoid hemorrhage

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047665
Enrollment
40
Registered
2022-11-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G973- Intraoperative hemorrhage and hematoma of a nervous system organ or structure complicating a procedure

Interventions

Intervention1: urokinase, recombinant tissue plasminogen activator or tenecteplase : 100 IU of tenecteplase, 50,000 IU of urokinase, or 1 mg of rtPA will be diluted upto 10ml and will be injected via

Sponsors

JIPMER PUDUCHERRY
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. Timepoint: at the time of discharge from the hospital.

Countries

India

Contacts

Public ContactAnirudh Gupta

jawaharlal institute of postgraduate medical education and research(JIPMER)

gopalakrishnanms@gmail.com9345141431

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026