To evaluate whether SAH patients treated by state-of-the-art SAH management with additional ultra-early and short term TXA administration have a significantly higher percentage of favourable outcome after six months (score 0-3 on the Modified Rankin…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Vascular haemorrhagic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical outcome evaluated with a modified Rankin Scale score after six months,
dichotomized into favourable and unfavourable outcome.
Secondary outcome
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
Background summary
Approximately 50% of all patients with a subarachnoid hemorrhage (SAH) die due
to the hemorrhage or subsequent complications. There are several major causes
for this course, such as in-hospital rebleed in 21.5% which most frequently
occurs within the first 6 hours after the primary hemorrhage (*ultra-early
rebleed*). A major part of the patients with a rebleed die during hospital
admission and when they survive, they develop more severe cognitive
dysfunctions. Reducing the rebleeds by ultra-early administration of tranexamic
acid (TXA) could be a major factor in improving the functional outcome after
SAH.
Study objective
To evaluate whether SAH patients treated by state-of-the-art SAH management
with additional ultra-early and short term TXA administration have a
significantly higher percentage of favourable outcome after six months (score
0-3 on the Modified Rankin Scale) compared to the group treated by up-to-date
SAH management without additional TXA.
Study design
Multicenter, prospective, randomized, open label treatment with blind endpoint
assessment.
Intervention
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 maximum of 24 hours. Control
group: standard treatment with no TXA administration. Both groups undergo a
standardized and validated interview at discharge and six months after
hemorrhage to assess the modified Rankin Scale score, and both groups receive a
questionnaire to evaluate health-care costs and quality of life.
Study burden and risks
Subjects are randomly allocated to ultra-early TXA therapy or standard
treatment. Complications are minor and the expected benefit is large compared
with separate studies done with antifibrinolytic medications. In these studies,
the safety of the use of these medications in this study population is
confirmed.
In this patient group there are adequate, disoriented and comatose patients on
admission, so a part of the studied patients are incapacitated when undergoing
the study. To extrapolate the conclusions of this study to clinical protocols
it is necessary to include patients with a SAH in all different severity
grades. Weighing carefully the benefits versus the burden and risks, it is
assumed that patients will benefit from ultra-early TXA administration with
minimal burden during therapy.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-000343-26-NL |
| CCMO | NL39577.018.12 |
| Other | NTR 11024 |