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

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 2

Conditions: Aspirin Treatment; Neurological Outcome; Traumatic Intracranial Bleed; Hemorrhage Growth

Treatments: Drug: platelets

Study type: Interventional

Funder types: Other

Identifiers

NCT01135862

CTIL-000-JR-08-TASMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

platelet administered

Experimental group

Description:

patients will receive 6 packs of platelets

Treatment:

Drug: platelets

no platelets administered

No Intervention group

Description:

patients will not receive platelets

Treatment:

Drug: platelets