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Medication therapy in aneurysmatic cerebral haemorrhage.

Tranexamic and acetylsalicylic acid after aneurysmatic subarachnoid haemorrhage.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27006
Enrollment
300
Registered
2009-02-17
Start date
2009-12-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Aneurysm Subarachnoid haemorrhage/hemorrhage Tranexamic acid, Cyklokapron Acetylsalicylic acid, Aspirin Aneurysma Subarachnoidale bloeding Tranexaminezuur Acetylsalicylzuur, Aspirine

Interventions

1. Group one: placebo administered intravenous in ten minutes, every four hours until four to eight hours preceding planned intervention followed by placebo every 24 hours until two weeks after aneury
2. Group two: 1 gram TA administrated intravenous in ten minutes, followed by a same dose every four hours until four to eight hours preceding planned intervention. In case of endovascular treatment,

Sponsors

Germans, M.R. Coert, B.A.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Aneurysmatic SAH less than 48 hours ago; 2. Age 18 years and older; 3. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Presence of deep vein thrombosis; 2. History of blood coagulation disorder; 3. Use of antiplatelet or anticoagulation medication during haemorrhage; 4. Immediate neurosurgical intervention necessary (with the exception of ventricular drainage); 5. Contraindication for use of aspirin; 6. Pregnancy; 7. Thrombocytopenia (150 mmol/L) or liver failure (AST > 150 U/l or ALT > 150 U/l or AF > 150 U/l or ã-GT > 150 U/l); 9. Imminent death within 24 hours.

Design outcomes

Primary

MeasureTime frame
Modified Rankin Scale.

Secondary

MeasureTime frame
1. In hospital possible or definite rebleed and interval with first haemorrhage; 2. Rebleed during endovascular or surgical treatment; 3. Thromboembolic events during endovascular treatment; 4. (Micro)infarctions on MR-imaging after treatment and after 6 months; 5. Hemorrhagic complications (intra and extracranial); 6. Extracranial thrombosis; 7. Treatment for hydrocephalus (lumbar puncture, lumbar or ventricular drainage); 8. Hemorrhagic complications with neurological deficit after placement of an extraventricular drain.

Contacts

Public ContactM.R. Germans
M.R.Germans@amc.uva.nl+31-(0)20-5663844

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)