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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46921

Enrollment

950

Registered

2012-08-14

Start date

2013-07-15

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

brain hemorrhage from a weak spot in an cerebral artery hemorrhage in the subarachnoid space

Interventions

TXA group: standard treatment with additional administration of 1 g TXA intravenously in ten minutes, immediately after the diagnosis SAH, succeeded by continuous infusion of 1 g per 8 hours until a

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Clinical outcome evaluated with a modified Rankin Scale score after six months, dichotomized into favourable and unfavourable outcome.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)