Platelet Administration To Patients With Traumatic Brain Injury Who Were Treated With Aspirin
- Conditions
- Aspirin TreatmentTraumatic Intracranial BleedHemorrhage GrowthNeurological Outcome
- Interventions
- Drug: platelets
- Registration Number
- NCT01135862
- Lead Sponsor
- Tel-Aviv Sourasky Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description platelet administered platelets patients will receive 6 packs of platelets no platelets administered platelets patients will not receive platelets
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
Tel-Aviv Sourasky Medical Center
🇮🇱Tel-Aviv, Israel