Aspirin Treatment, Traumatic Intracranial Bleed, Hemorrhage Growth, Neurological Outcome
Conditions
Brief summary
Traumatic brain injury (TBI) is a devastating disease with high morbidity and mortality. Although not fully proved, it is commonly accepted that the morbidity and mortality and proportional to the extent of intracranial bleeds (i.e. - larger hemorrhages cause more injury than smaller ones). Aspirin is a commonly used antiaggregate drug that interferes with the clotting system. The antiaggregate effect may be neutralized by administration of platelets. Thus, potentially, patients receiving Aspirin and undergoing TBI, are at a higher risk for increasing an intracranial bleed. In this prospective study, the investigators randomize patients receiving aspirin that have a traumatic intracranial bleed to two groups, one - that will receive platelets, and the other that will not receive platelets. The primary end point of the study is to evaluate the effect of platelet administration of the enlargement of traumatic intracranial bleeds, and try and evaluate any clinical outcome differences between the two groups.
Detailed description
Traumatic brain injury (TBI) is a devastating disease with high morbidity and mortality. Although not fully proved, it is commonly accepted that the morbidity and mortality and proportional to the extent of intracranial bleeds (i.e. - larger hemorrhages cause more injury than smaller ones). Aspirin is a commonly used antiaggregate drug that interferes with the clotting system. The antiaggregate effect may be neutralized by administration of platelets. Thus, potentially, patients receiving Aspirin and undergoing TBI, are at a higher risk for increasing an intracranial bleed. In this prospective study, we randomize patients receiving aspirin that have a traumatic intracranial bleed to two groups, one - that will receive platelets, and the other that will not receive platelets. The primary end point of the study is to evaluate the effect of platelet administration of the enlargement of traumatic intracranial bleeds, and try and evaluate any clinical outcome differences between the two groups.
Interventions
DRUGplatelets
6 packs of platelets will be administered
Sponsors
Tel-Aviv Sourasky Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \>18 years old * chronic aspirin treatment * first CT scan less than 12 hours following the trauma * GCS \>3 * no immediate surgical cranial lesion * isolated head injury * consent * contusions \>1.5cc or acute subdural hemorrhage in any size
Exclusion criteria
* anticoagulation treatment * more than one antiaggregate * coagulopathy * thrombocytopenia (less than 100000) * intracranial tumor * active hematological disease * more than 8 hours between first and second CT scan * more than 2 hours between first CT and platelet admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy of platelet administration in lowering the rate of early hemorrhagic growth within 6 hours | 6 hours |
| are lower aspirin doses a risk for early hemorrhagic growth | 6 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| vascular complications | within 1 month from platelet admission | vascular complications include active ischemic heart disease (MI, unstable angina), ischemic stroke, acute peripheral vasculopathy, deep vein thrombosis, and pulmonary emboli these complications will be diagnosed clinically and not by screening procedures. |
| complications attributed to platelets as listed below | within 1 week | these complications include an exacerbation of congestive heart failure, or any allergic reaction to platelet admission such as fever, rigor, rash, hemodynamic collapse occuring within 6 hours of platelet admission. other events which will be attributed to platelet admission are sepsis \<48 hours after platelet admission or new thrombocytopenia occurring within 1 week after admission of platelets. |
| difference in neurological outcome between both groups | 1 month, 6 months, and 1 year after the traumatic brain injury | as evaluated by Glasgow Outcome Score (GOS) |
Countries
Israel
Contacts
Primary ContactJonathan Roth
Outcome results
None listed