Intracerebral HemorrhageNCT00699621
Platelet Transfusion in Acute Intracerebral Hemorrhage
A study testing platelets in people with Intracerebral Hemorrhage, run by University of Oulu at 1 site in Finland.
Trial summary
To prove whether use of antiplatelet agents results into a rapid enlargement of hematoma after onset of acute intracerebral hemorrhage. To prove the efficacy and safety of platelet transfusion for prevention of hematoma growth in patients who were stricken by acute intracerebral hemorrhage while being on antiplatelet… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- platelets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2009to Dec 2014
- Phase
- Interventional
- 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
Who may be able to join
- being on either aspirin or clopidogrel or a combination of aspirin and dipyridamole
- acute primary ICH
- > 17 years
- admitted within 6 h after onset of ICH
- ICH score < 4
Who cannot join
- other type of ICH than acute primary intracerebral hemorrhage
- patients who need neurosurgery
- life expectancy less than 3 months due to comorbid disorders
- confirmed malignant disease (cancer)
- confirmed acute myocardial infarction
- hepatitis and/liver cirrhosis
Show all 11Show fewer
- renal failure
- infectious disease (HIV, endocarditis etc.)
- current or previous hematologic disease
- women of childbearing age if pregnant
- participation in another study within the preceding 30 days
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Department of Neurology, Oulu University Hospital
Oulu, 90029 OYS
Matti E Hillbom, MD, PhD, 358-8-315-4518, matti.hillbom@oulu.fi
Juha T Huhtakangas, MD, 358-8-315-4032, juha.huhtakangas@ppshp.fi
About this study
Official title: Platelet Transfusion in Acute Primary Intracerebral Hemorrhage for Patients on Platelet Inhibitors
- To prove whether use of antiplatelet agents results into a rapid enlargement of hematoma after onset of acute intracerebral hemorrhage.
- To prove the efficacy and safety of platelet transfusion for prevention of hematoma growth in patients who were stricken by acute intracerebral hemorrhage while being on antiplatelet medication.
Read the detailed description
- Hematoma growth is a well-known powerful determinant of mortality and poor outcome after intracerebral hemorrhage.
- Some observations suggest that previous use of antiplatelet agents associates with rapid hematoma enlargement and poor outcome after cerebral hemorrhage.
- Immediate platelet transfusion for such patients may prevent hematoma growth but also cause thromboembolic complications.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- platelets
- Keywords
- Intracerebral hemorrhage, Hematoma enlargement, Antiplatelet agent, Platelet transfusion, Outcome
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plateletsBiological
Four units of fresh platelets will be infused immediately
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Platelet transfusion Receives: Biological: platelets |
| 2 | No intervention | No platelet transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematoma growth within 24 h measured as increase in hematoma volume observed by head CT
Measured: 24 hours
Secondary outcomes (5)
Glasgow Outcome Score
Measured: 90 days
Cardiovascular death occurring within the treatment period
Measured: 90 days
Death due to any cause occurring within the treatment period
Measured: 90 days
Acute myocardial infarction
Measured: 90 days
Venous thromboembolism
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJan 2009
- Primary completionJul 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Investigators
- Matti E Hillbom, MD, PhD, Study chair, Oulu University Central Hospital, Department of NeurologySeppo S Juvela, MD, PhD, Study director, Turku University Central Hospital, Department of NeurosurgeryLauri Soinne, MD, PhD, Principal investigator, Helsinki University Central Hospital, Department of NeurologyOlli Häppölä, MD, PhD, Study director, Helsinki University Central HospitalAimo Rissanen, MD, PhD, Principal investigator, Keski-Suomen Keskussairaala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699621
- Sponsor's protocol ID
- A-1 EUDRACT 2007-006206-24
- Status last verified
- Jul 2010
- First submitted
- 12 Jun 2008
- Last updated
- 2 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.
PubMed 37870112
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Transfusion in Acute Primary Intracerebral Hemorrhage for Patients on Platelet Inhibitors
- ClinicalTrials.gov ID
- NCT00699621
- Acronym / sponsor ID
- A-1 EUDRACT 2007-006206-24
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Intracerebral hemorrhage, Hematoma enlargement, Antiplatelet agent, Platelet transfusion, Outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- Jan 2009
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 18 Jun 2008 (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.
- To prove whether use of antiplatelet agents results into a rapid enlargement of hematoma after onset of acute intracerebral hemorrhage.
- To prove the efficacy and safety of platelet transfusion for prevention of hematoma growth in patients who were stricken by acute intracerebral hemorrhage while being on antiplatelet medication.
Detailed description
- Hematoma growth is a well-known powerful determinant of mortality and poor outcome after intracerebral hemorrhage.
- Some observations suggest that previous use of antiplatelet agents associates with rapid hematoma enlargement and poor outcome after cerebral hemorrhage.
- Immediate platelet transfusion for such patients may prevent hematoma growth but also cause thromboembolic complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: plateletsPlatelet transfusion |
| 2 | No intervention | –No platelet transfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- being on either aspirin or clopidogrel or a combination of aspirin and dipyridamole
- acute primary ICH
- > 17 years
- admitted within 6 h after onset of ICH
- ICH score < 4
Key exclusion criteria (11 listed)
- other type of ICH than acute primary intracerebral hemorrhage
- patients who need neurosurgery
- life expectancy less than 3 months due to comorbid disorders
- confirmed malignant disease (cancer)
- confirmed acute myocardial infarction
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 |
|---|---|---|
| plateletsFour units of fresh platelets will be infused immediately | Biological | 1 |
Primary outcome
Hematoma growth within 24 h measured as increase in hematoma volume observed by head CT
Time frame: 24 hours
5 secondary outcomes
Glasgow Outcome Score
Time frame: 90 days
Cardiovascular death occurring within the treatment period
Time frame: 90 days
Death due to any cause occurring within the treatment period
Time frame: 90 days
Acute myocardial infarction
Time frame: 90 days
Venous thromboembolism
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2010.
- Derived from this study: PubMed 37870112Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.
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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.
Matti E Hillbom, MD, PhD study chair
Oulu University Central Hospital, Department of Neurology
Seppo S Juvela, MD, PhD study director
Turku University Central Hospital, Department of Neurosurgery
Lauri Soinne, MD, PhD principal investigator
Helsinki University Central Hospital, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelets in people with Intracerebral Hemorrhage, run by University of Oulu 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 2 Jul 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matti E Hillbom, MD, PhD (358-8-315-4518, matti.hillbom@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematoma growth within 24 h measured as increase in hematoma volume observed by head CT (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00699621, which also lists 1 linked publication.
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 2 Jul 2010.