Status:

TERMINATED

Safety of Platelet Transfusion in Patients on Antiplatelet Therapy With Traumatic Head Injury

Lead Sponsor:

Christiana Care Health Services

Collaborating Sponsors:

United States Department of Defense

Conditions:

Traumatic Head Injury

Intracranial Hemmorhage

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The objective of this study is to determine if the administration of platelets will improve outcome in patients with ICH who are being treated with either aspirin, a thienopyridine (ticlodipine, clopi...

Detailed Description

Intracranial hemorrhage (ICH), or bleeding in the brain, is the major cause of death in trauma patients. The initial volume and early growth of the hematoma are critical determinants of mortality and ...

Eligibility Criteria

Inclusion

  • 18 years or older
  • Evidence of intracranial hemorrhage (bleeding in the brain) by CT scan related to traumatic injury
  • Receiving antiplatelet therapy such as aspirin, thienopyridine (ticlopidine, clopidogrel, or prasugrel)
  • Platelet count greater than or equal to 100,000

Exclusion

  • Glasgow Coma Scale (GCS) less than 6
  • Hemorrhage requiring emergent surgery
  • Lack of permission from treating physician and/or consultant
  • Secondary ICH related to aneurysm or arteriovenous malformation
  • Use of oral anticoagulants
  • Decreased platelets (thrombocytopenia)
  • Patients requiring massive transfusion protocol
  • Life expectancy less than 3 months
  • Confirmed acute heart attack
  • Hepatitis and liver cirrhosis
  • Kidney failure
  • Participation in another treatment study within the preceding 30 days

Key Trial Info

Start Date :

June 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2013

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT01810276

Start Date

June 1 2012

End Date

April 1 2013

Last Update

April 18 2017

Active Locations (1)

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Christiana Care Health System, Christiana Hospital

Newark, Delaware, United States, 19718