Aneurysmatic Subarachnoid Haemorrhage Clinical Trial
Official title:
Coagulation Disorders After Aneurysmatic Subarachnoid Haemorrhage
| NCT number | NCT02540005 |
| Other study ID # | 230215-1 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | September 1, 2015 |
| Last updated | June 27, 2016 |
| Start date | September 2015 |
The main purpose of this study is to analyse the on-going coagulation process after aSAH. For investigation the investigators use the rotational thromboelastometry (ROTEM) which is a point-of-care test using a variety of activators to provide a targeted and a dynamic analysis of coagulation cascade. This is a prospective, observational clinical study done in 16 aSAH patients treated in Tampere University Hospital intensive care unit and 16 control patients (elective craniotomy due to non-ruptured intracranial aneurysm.
| Status | Completed |
| Enrollment | 32 |
| Est. completion date | |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Age = 18 years - Acute subarachnoid haemorrhage (confirmed by computed tomography, CT, or cerebrospinal fluid erythrocyte count over 1000 x 106/l) AND confirmed origin either with computed angiography (CTA) or digital subtraction angiography (DSA) - Onset of symptoms = 12 hours - Expected to stay 72 hours in the ICU Exclusion Criteria: - Pregnancy - Any long-term anticoagulant medication, except for low-dose aspirin (<150 mg/day) - Known active cancer |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Finland | Tampere University Hospital | Tampere | Pirkanmaa |
| Lead Sponsor | Collaborator |
|---|---|
| Tampere University Hospital | CSL Behring |
Finland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | ROTEM analysis: MCF (mm) by EXTEM activators | 12 hours | No |