ltra-early tranexamic acid after subarachnoid hemorrhage. A prospective, randomized, multicenter study.

Phase 3

Completed

Conditions: 10047075
brain hemorrhage from a weak spot in an cerebral artery
10007963
hemorrhage in the subarachnoid space

Registration Number: NL-OMON46921

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 950

Inclusion Criteria

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

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 or pulmonary embolism
• History of blood coagulation disorder (a hypercoagulability disorder)
• Pregnancy checked with a pregnancy test in women in their childbearing period
• History of severe renal (serum creatinin > 150 mmol/L) failure
• Imminent death within 24 hours

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Clinical outcome evaluated with a modified Rankin Scale score after six months,<br /><br>dichotomized into favourable and unfavourable outcome. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. If patient has deceased: the date and cause of death<br /><br>2. Cause of poor outcome<br /><br>3. Possible or definite rebleed, rebleed volume, and time interval with first<br /><br>hemorrhage<br /><br>4. Rebleed during endovascular or surgical treatment<br /><br>5. Thromboembolic events during endovascular treatment<br /><br>6. Delayed cerebral ischemia (DCI)<br /><br>7. Extracranial thrombosis<br /><br>8. Treatment for hydrocephalus (therapeutic lumbar puncture, lumbar or<br /><br>ventricular drainage or definitive shunt)<br /><br>9. Hemorrhagic complications (intra- and extracranial)<br /><br>10. Time interval from last hemorrhage to TXA administration<br /><br>11. Discharge location<br /><br>12. Infarctions and infarctions volumes on MRI imaging at six months after<br /><br>endovascular treatment<br /><br>13. Health-care costs between discharge and six months after hemorrhage<br /><br>14. Quality of life six months after hemorrhage<br /><br>15. Gender<br /><br>16. WFNS grade at admittance</p><br>