The objective of our study is to investigate whether platelet transfusion within 6 hours after onset of ICH can improve functional outcome by limiting haematoma growth in patients using PAI.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Vascular haemorrhagic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Three months after randomisation patients functional health outcome is scored
on the modified Rankin Scale (mRS), poor outcome is defined as a score of 3-6.
Secondary outcome
- Haematoma growth: the difference in haematoma volume between the first
CT-scan and a repeat scan after 24 hours (assessed by a radiologist blinded for
treatment)
- Predictive value of PFA-100 test results regarding benefit from platelet
transfusion
- Differences in PFA-100 results before and after platelet transfusion
- Percentage of patients with PFA-100 results in the Emergency Department
within 30 minutes
- Predictive value of the CTA 'spot sign' regarding benefit from platelet
transfusion
- Predictive value of the CTA "spot sign" regarding haematoma enlargement on CT
- Complications of platelet transfusion (thrombotic, infectious, transfusion
reactions)
- Survival at 3 months
- Disability at 3 months using the AMC linear disability score (ALDS) assessed
in telephone interview by trained research nurses, blinded for treatment
allocation
- Patient*s functional health using the full ordinal scoring range of the
modified ranking scale at 3 months
- Poor outcome at 3 months defined as a mRS score of 3-6
- Cause of poor outcome assessed by a Classification Committee of experienced
neurologists
- Costs
Background summary
Stroke is a major cause of acquired disability in the Netherlands. After the
care for children born with a handicap, the care for stroke patients consumes
the largest portion of the total health care budget.
In recent years acute treatment in ischemic stroke improved significantly.
Thrombolysis within 3 hours was shown to improve clinical outcome. However, for
haemorrhagic stroke or intracerebral haemorrhage (ICH), which accounts for 15%
of all stroke patients, no acute treatment option currently exists.
Haematoma volume is one of the most important outcome predictors in ICH.
Because several studies have shown that haematoma volume increases during the
first 6 hours after onset of ICH, reduction of this haematoma growth provides a
promising target to improve outcome. Patients using platelet aggregation
inhibitors (PAI) are especially at risk for haematoma growth and therefore
platelet transfusion (PT) is an acute treatment option which should be
investigated.
Study objective
The objective of our study is to investigate whether platelet transfusion
within 6 hours after onset of ICH can improve functional outcome by limiting
haematoma growth in patients using PAI.
Study design
Multicenter study in 30 Dutch hospitals.
Probe: Prospective, Randomised, Open treatment, Blind End-point evaluation
Intervention
Patients are randomised to receive a single gift of platelets (5 or 10 donor
units) within 6 hours after start of symptoms or standard care without platelet
transfusion.
Study burden and risks
The extra burden for the patients consists of one CT scan of the brain and in
selected centres a CT angiography of the cerebral circulation. A blood sample
will be collected two times to measure platelet function.
The risk for patients receiving platelet transfusion consists of transfusion
reactions. There is a 1-6% chance of experiencing such a reaction. Most
transfusion reactions are harmless. In less than 0.1% the reaction is serious.
The expected risk of thrombo-embolic complications in patients without
thrombocytopenia is negligible.
Meibergdreef 9
1100 DD Amsterdam
NL
Meibergdreef 9
1100 DD Amsterdam
NL
Listed location countries
Age
Inclusion criteria
- Age 18-75 years
- Patients with non-traumatic, supratentorial ICH confirmed by CT
- Haematoma volume < 150 cc
- Glagow Coma Scale score 8-15
- Platelet aggregation inhibitors used at least seven days preceding haemorrhage
- Treatment can be initiated within 6 hours after onset of first signs and within 1* hours of the CT scan
- Pre-stroke Rankin scale score 0 or 1 (No symptoms, No significant disability despite
symptoms; able to carry out all usual duties and activities)
Exclusion criteria
- Haematoma on CT compatible with epidural, subdural, aneurysmal or arterio-venous malformation (AVM) haematoma
- Planned surgical evacuation of haematoma within 24 hours after admission
- Presence of intraventricular blood if more than sedimentation in the posterior horns of the lateral ventricles
- Previous adverse reaction after platelet transfusion
- Previously legally incompetent adults
- Death appears imminent
- Known use of vitamin K antagonists (unless INR < 1.3)
- Known thrombocytopenia < 100 x 10E9/l
- History of coagulopathy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL16450.018.08 |
| OMON | NL-OMON28517 |