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.

Study Overview

• Status: Unknown
• Conditions: Neurological Outcome; Aspirin Treatment; Traumatic Intracranial Bleed; Hemorrhage Growth
• Intervention / Treatment: Drug: platelets

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Tel-Aviv, Israel
    • Tel-Aviv Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: platelet administered; patients will receive 6 packs of platelets	Drug: platelets; 6 packs of platelets will be administered
No Intervention: no platelets administered; patients will not receive platelets	Drug: platelets; 6 packs of platelets will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Jonathan Roth, MD, Tel-Aviv Sorasky Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): June 1, 2011
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: March 8, 2010
• First Submitted That Met QC Criteria: June 2, 2010
• First Posted (Estimate): June 3, 2010

Study Record Updates

• Last Update Posted (Estimate): June 3, 2010
• Last Update Submitted That Met QC Criteria: June 2, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Hemorrhage; Brain Injuries, Traumatic; Intracranial Hemorrhages
• Other Study ID Numbers: CTIL-000-JR-08-TASMC