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

Sponsor

Christiana Care Health Services (Other)

Overall Status

Terminated

CT.gov ID

NCT01810276

Collaborator

United States Department of Defense (U.S. Fed)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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, clopidogrel, prasugrel) or a combination of both. The study has four specific aims:

To determine what affect platelet administration will have on bleeding in the brain.
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.
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.
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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Head Injury Intracranial Hemmorhage Anti-platelet Therapy	Other: Saline Other: Platelets	N/A

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 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Safety and Efficacy of Platelet Transfusion in Patients Receiving Antiplatelet Therapy That Sustain Traumatic Intracranial Hemorrhage

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Saline 400 mL of Saline will be given intravenously over 2 hours once.	Other: Saline 400 mL of Saline will be given intravenously over 2 hours once
Active Comparator: Platelets 2 apheresis units of platelets (approximately 200 ml) will be given intravenously over 2 hours.	Other: Platelets 2 apheresis units of platelets (approximately 200 ml) will be given intravenously over 2 hours.

Arm

Intervention/Treatment

Placebo Comparator: Saline

400 mL of Saline will be given intravenously over 2 hours once.

Other: Saline

400 mL of Saline will be given intravenously over 2 hours once

Active Comparator: Platelets

2 apheresis units of platelets (approximately 200 ml) will be given intravenously over 2 hours.

Other: Platelets

2 apheresis units of platelets (approximately 200 ml) will be given intravenously over 2 hours.

Outcome Measures

Primary Outcome Measures

Hemorrhage growth [24 hours]
Bleeding in the brain will be measured by computerized tomography scan (CT Scan) 24 hours after study treatment is completed.

Secondary Outcome Measures

Neurological Outcome [Assessments to determine brain function or neurological outcome will be performed at enrollment, time of study treatment, 1 and 24 hours post treatment, days 2, 3, and 10 (or time of discharge) and at 90 days post treatment.]
Assessments to determine brain function or neurological outcome will be performed at enrollment, time of study treatment, 1 and 24 hours post treatment, days 2, 3, and 10 (or time of discharge) and at 90 days post treatment.

Other Outcome Measures

Thromboembolic complications [Complications will be monitored enrollment, time of study treatment, 1 and 24 hours post treatment, days 2, 3, and 10 (or time of discharge)and at 90 days post treatment.]
Complications such as heart attack, stroke, venous thromboembolic, and death which can be caused by reversing antiplatelet therapy will be monitored enrollment, time of study treatment, 1 and 24 hours post treatment, days 2, 3, and 10 (or time of discharge)and at 90 days post treatment.
Platelet responsiveness [1 hour and 24 hours post study treatment]
Platelet responsiveness will be measured by lab test at 1 and 24 hours post study treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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