Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date June 2016
Source Tampere University Hospital
Contact n/a
Is FDA regulated No
Health authority Finland: Valvira - National Supervisory Authority for Welfare and Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
ROTEM analysis


Locations

Country Name City State
Finland Tampere University Hospital Tampere Pirkanmaa

Sponsors (2)

Lead Sponsor Collaborator
Tampere University Hospital CSL Behring

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary ROTEM analysis: MCF (mm) by EXTEM activators 12 hours No