Platelet Administration To Patients With Traumatic Brain Injury Who Were Treated With Aspirin

Study Overview
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Brief Summary
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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
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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.

Official Title
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Platelet Administration To Patients With Traumatic Brain Injury Who Were Treated With Aspirin

Conditions
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Aspirin Treatment, Traumatic Intracranial Bleed, Hemorrhage Growth, Neurological Outcome

Intervention / Treatment
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* Drug: platelets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: platelet administered<br>patients will receive 6 packs of platelets | Drug: platelets<br>* 6 packs of platelets will be administered<br>|
| No Intervention: no platelets administered<br>patients will not receive platelets | Drug: platelets<br>* 6 packs of platelets will be administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vascular complications | 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. | within 1 month from platelet admission | 
| complications attributed to platelets as listed below | 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. | within 1 week | 
| difference in neurological outcome between both groups | as evaluated by Glasgow Outcome Score (GOS) | 1 month, 6 months, and 1 year after the traumatic brain injury |