Safety of Platelet Transfusion in Patients on Antiplatelet Therapy With Traumatic Head Injury
Stopped early · Not applicable
Conditions studied: Traumatic Head Injury, Intracranial Hemmorhage, Anti-platelet Therapy
In brief
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, clopidogrel, prasugrel) or a combination of both. The study has four specific aims: 1. To determine what affect platelet administration will have on bleeding in the brain. 2. To determine what affect platelet administration will have on brain function. Several assessments to test the functioning of the brain will be performed at enrollment and throughout the study. Comparing the results of these assessments between the experimental and control groups should allow us to determine if platelet administration improves outcomes in patients with bleeding in the brain exposed to antiplatelet therapy. 3. An important risk of reversing antiplatelet therapy is exposing the patient to the very complications this therapy was designed to prevent. Therefore, tracking complications will be a very important part of this study. The investigators will compare the rates of death, heart attack, stroke and clots in the veins between groups. 4. Some patients (10-40%) have limited responsiveness to antiplatelet therapy. While platelet responsiveness, as measured by a special platelet blood test, will not affect enrollment, the investigators feel it will be important to measure.
Key facts
- Study ID
- NCT01810276
- Run by
- Christiana Care Health Services
- People needed
- 40
- Starts
- 2012-06-01
- Expected to finish
- 2013-04-01
- Last updated by the study team
- 2017-04-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Christiana Care Health System, Christiana Hospital — Newark, Delaware, United States
Full record on ClinicalTrials.gov
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