Neurological Outcome Clinical Trial
Official title:
Platelet Administration To Patients With Traumatic Brain Injury Who Were Treated With Aspirin
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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