ISCHEMIA

Phase 1

Active, not recruiting

• Conditions: subarachnoid hemorrhage; MedDRA version: 21.1Level: PTClassification code: 10042316Term: Subarachnoid haemorrhage Class: 100000004852; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2024-511679-14-00
• Lead Sponsor: Amsterdam UMC Stichting

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-24
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

SAH confirmed by CT or lumbar puncture with the causative aneurysm confirmed by CT-A and/or DSA, Coiling of the causative aneurysm within 72 hours of initial SAH, Informed consent before the first scheduled administration of the study medicine, Adult age (=18 years)

Exclusion Criteria

Stent-assisted coiling, Use of anticoagulant or dual antiplatelet medication post-coiling for other reasons, Incomplete aneurysm occlusion/partial coiling, Intraparenchymal hemorrhage, Pregnancy, Contra-indications for LMWH: oPrevious history of history of heparin-induced thrombocytopenia o(Suspicion of) active arterial or venous bleeding oPrevious history of hemorrhagic diathesis due to coagulation disorders (with the ex-ception of disseminated intravascular coagulation) oSevere hypertension: uncontrolled hypertension with a MAP > 135mmHg oPrevious history of hypertensive or diabetic retinopathy oPrevious history of active infectious endocarditis oSevere renal impairment (creatinine clearance <30 mL / min), No proficiency of Dutch or English language, Proven and active COVID-19 infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified