Clinical trial NCT01135862: Platelet Administration To Patients With Traumatic Brain Injury Who Were Treated With Aspirin
Official title: Platelet Administration To Patients With Traumatic Brain Injury Who Were Treated With Aspirin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Aspirin Treatment
Traumatic Intracranial Bleed
Hemorrhage Growth
Neurological Outcome
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-06-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: efficacy of platelet administration in lowering the rate of early hemorrhagic growth within 6 hours
timeFrame: 6 hours
measure: are lower aspirin doses a risk for early hemorrhagic growth
timeFrame: 6 hours
Secondary outcomes:
measure: vascular complications
timeFrame: within 1 month from platelet admission
measure: complications attributed to platelets as listed below
timeFrame: within 1 week
measure: difference in neurological outcome between both groups
timeFrame: 1 month, 6 months, and 1 year after the traumatic brain injury
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sorasky Medical Center
name: Jonathan Roth, MD
role: PRINCIPAL_INVESTIGATOR
References: