subarachnoid hemorrhage
Conditions
Interventions
Trade Name: Cyklokapron
Product Name: Cyklokapron
Pharmaceutical Form: Solution for injection
Sponsors
Academic Medical Center, Neurosurgery
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether a group of patients with subarachnoid hemorrhage (SAH) treated by standard, state-of-the-art SAH management with additional ultra-early and short-term tranexamic acid (TXA) administration (TXA group) has a significantly higher percentage of patients with a favourable outcome after six months (score 0-3 on the Modified Rankin Scale) compared to a group treated by standard, state-of-the-art SAH management without additional TXA administration (control group).;Secondary Objective: To evaluate significant differences between the TXA group and the control group in: • case fatality rate at discharge and 6 months after SAH • rebleed rate before or during treatment • thromboembolic complications during endovascular treatment • delayed cerebral ischemia rate • complications, such as hydrocephalus, extracranial thrombosis or hemorrhagic complications, during admission and at 6 months after SAH • (micro)infarctions on MR imaging at 6 months after endovascular treatment • care costs 6 months after SAH • quality of life 6 months after SAH • To evaluate whether there is a significant association between favourable outcome at six months after SAH and time between ictus and TXA administration • To evaluate whether there is a significant difference in rebleeds and favourable outcome between females and males and between patients in different WFNS groups at admittance • To evaluate the cause of poor outcome ;Primary end point(s): Clinical outcome assessed by the Modified Rankin Scale Score dichotomized as a favourable (0-3) or unfavourable (4-6) outcome.;Timepoint(s) of evaluation of this end point: 6 months after SAH | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: case fatality rate 2: rebleed rate 3: thromboembolic complications 4: delayed cerebral ischemia rate 5: complications (hydrocephalus, extracranial thrombosis or hemorrhagic complications) 6: (micro)infarctions on MR imaging 7: care costs 8: quality of life ;Timepoint(s) of evaluation of this end point: 1: six months after SAH 2: before or during aneurysm treatment 3: during endovascular treatment 4: during admission 5: during admission and at six months after SAH 6: six months after endovascular treatment 7: six months after SAH 8: six months after SAH | — |
Countries
Netherlands
Contacts
Public ContactULTRA contact point
Academic Medical Center Amsterdam
Outcome results
None listed