NCT02540005

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

June 28, 2016

Status Verified

June 1, 2016

Enrollment Period

9 months

First QC Date

September 1, 2015

Last Update Submit

June 27, 2016

Conditions

Aneurysmatic Subarachnoid Haemorrhage

Outcome Measures

Primary Outcomes (1)

  • ROTEM analysis: MCF (mm) by EXTEM activators

    12 hours

Study Arms (2)

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)

Other: ROTEM analysis

Control patients

Elective craniotomy due to non-ruptured intracranial aneurysm

Other: ROTEM analysis

Interventions

ROTEM analysisOTHER
Aneurysmatic subarachnoid haemorrhageControl patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute aneurysmal subarachnoid haemorrhage patients

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Any long-term anticoagulant medication, except for low-dose aspirin (\<150 mg/day)
  • Known active cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, Pirkanmaa, 33521, Finland

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 1, 2015

First Posted

September 3, 2015

Study Start

September 1, 2015

Primary Completion

June 1, 2016

Last Updated

June 28, 2016

Record last verified: 2016-06

Locations

FI(1)