Aneurysmatic Subarachnoid HaemorrhageNCT02540005
Coagulation Disorders After Aneurysmatic Subarachnoid Haemorrhage
An observational study of Aneurysmatic Subarachnoid Haemorrhage, run by Tampere University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmatic Subarachnoid Haemorrhage
- What is being tested?
- ROTEM analysis
- How many people
- 32 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute aneurysmal subarachnoid haemorrhage patients
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Any long-term anticoagulant medication, except for low-dose aspirin (<150 mg/day)
- Known active cancer
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Aneurysmatic Subarachnoid Haemorrhage
- Being tested
- ROTEM analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROTEM analysisOther
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: ROTEM analysis | |
| Control patients | Elective craniotomy due to non-ruptured intracranial aneurysm Receives: Other: ROTEM analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROTEM analysis: MCF (mm) by EXTEM activators
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmatic Subarachnoid HaemorrhageStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CSL Behring
- Responsible party
- Principal investigator, Annukka Vahtera, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540005
- Sponsor's protocol ID
- 230215-1
- Status last verified
- Jun 2016
- First submitted
- 1 Sep 2015
- Last updated
- 28 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coagulation Disorders After Aneurysmatic Subarachnoid Haemorrhage
- ClinicalTrials.gov ID
- NCT02540005
- Acronym / sponsor ID
- 230215-1
- Conditions
- Aneurysmatic Subarachnoid Haemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- CSL Behring
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- First posted
- 3 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aneurysmatic subarachnoid haemorrhage | – | Other: ROTEM analysisAcute 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) |
| Control patients | – | Other: ROTEM analysisElective craniotomy due to non-ruptured intracranial aneurysm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute aneurysmal subarachnoid haemorrhage patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Any long-term anticoagulant medication, except for low-dose aspirin (<150 mg/day)
- Known active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ROTEM analysis | Other | Aneurysmatic subarachnoid haemorrhage, Control patients |
Primary outcome
ROTEM analysis: MCF (mm) by EXTEM activators
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysmatic Subarachnoid Haemorrhage, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROTEM analysis: MCF (mm) by EXTEM activators (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2016.