ltra-early tranexamic acid after subarachnoid hemorrhage.

Phase 1

• Conditions: subarachnoid hemorrhage; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-000343-26-NL
• Lead Sponsor: Academic Medical Center, Neurosurgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-14
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 950

Inclusion Criteria

• Admission to one of the study centers or their referring hospitals
• CT-confirmed SAH with most recent ictus less than 24 hours ago
• Age 18 years and older

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 730
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 220

Exclusion Criteria

• No proficiency of the Dutch or English language
No loss of consciousness after the hemorrhage with World Federation of Neurological Surgeons (WFNS) grade 1 or 2 on admission in combination with a perimesencephalic hemorrhage
• Bleeding pattern on CT compatible with a traumatic SAH
• Treatment for deep vein thrombosis
• History of blood coagulation disorder
• Pregnancy
• Severe renal (serum creatinin >150 mmol/L) or liver failure (AST > 150 U/l or ALT > 150 U/l or AF > 150 U/l or ?-GT > 150 U/l)
• Imminent death within 24 hours

Study & Design

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