Coagulation Disorders After Aneurysmatic Subarachnoid Haemorrhage

NCT ID: NCT02540005

Last Updated: 2016-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Brief Summary

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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

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Conditions

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Aneurysmatic Subarachnoid Haemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aneurysmatic subarachnoid haemorrhage

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)

ROTEM analysis

Intervention Type OTHER

Control patients

Elective craniotomy due to non-ruptured intracranial aneurysm

ROTEM analysis

Intervention Type OTHER

Interventions

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ROTEM analysis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CSL Behring

INDUSTRY

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Annukka Vahtera

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tampere University Hospital

Tampere, Pirkanmaa, Finland

Site Status

Countries

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Finland

Other Identifiers

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230215-1

Identifier Type: -

Identifier Source: org_study_id

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