Safety of Platelet Transfusion in Patients on Antiplatelet Therapy With Traumatic Head Injury
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/3/2013 |
| Start Date: | June 2012 |
| End Date: | April 2013 |
| Contact: | Debra R. Marco, RN, BSN, CCRC |
| Email: | DMarco@christianacare.org |
| Phone: | 302-733-4130 |
The Safety and Efficacy of Platelet Transfusion in Patients Receiving Antiplatelet Therapy That Sustain Traumatic Intracranial Hemorrhage
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.
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 functional outcome. As our population ages, a significant and
growing number of patients present with ICH while on antiplatelet therapy. Bleeding is a
well known complication of this therapy. It is likely that patients with ICH who are
exposed to antiplatelet therapy would have an increased risk of hemorrhage growth and poor
outcome compared to patients that are not using antiplatelet therapy. There are no
pharmacologic agents that can reverse the antithrombotic effect of aspirin or the
thienopyridines. There is a paucity of published data, one small phase one trial and two
retrospective studies that address the use of platelets as a means to reverse the effects of
antiplatelet therapy in patients suffering ICH. In addition, transfusion of platelets may
be associated with transfusion reactions, such as infection and fluid overload. Furthermore,
these patients are then exposed to the very thromboembolic complications the antiplatelet
therapy was designed to prevent.
Given the lack of data, which is primarily retrospective and likely underpowered, The
investigators feel it's important to conduct a trial to more definitively study the efficacy
of antiplatelet reversal in patients with life threatening ICH. Furthermore, it would be
important to understand that, if there is a benefit to antiplatelet reversal in patients
with ICH, that this benefit will outweigh the risks of antiplatelet reversal.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
1
site
4755 Ogletown-Stanton Road
Newark, Delaware 19718
Newark, Delaware 19718
302-733-1000
Christiana Care Health System - Christiana Hospital A 913-bed, 1.3-million-square-foot, modern facility in Newark, Delaware,...
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