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

• Status: Unknown status
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tel-Aviv Sourasky Medical Center
• Treatments: Aspirin

Criteria

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