Coagulation Disorders After Aneurysmatic Subarachnoid Haemorrhage

Completed

• Conditions: Aneurysmatic Subarachnoid Haemorrhage
• Interventions: Other: ROTEM analysis

• Registration Number: NCT02540005
• Lead Sponsor: Tampere University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-09-02
• Study First Posted: 2015-09-03
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Last Update Submitted: 2016-06-27
• Last Update Posted: 2016-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control patients	ROTEM analysis	Elective craniotomy due to non-ruptured intracranial aneurysm
Aneurysmatic subarachnoid haemorrhage	ROTEM analysis	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)

Primary Outcome Measures

Name	Time	Method
ROTEM analysis: MCF (mm) by EXTEM activators	12 hours

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Pirkanmaa, Finland