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

NCT ID: NCT01810276

Last Updated: 2017-04-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-04-30

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:

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.

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.

Conditions

Traumatic Head Injury; Intracranial Hemmorhage; Anti-platelet Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Saline

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

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: OTHER

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

Platelets

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

Group Type: ACTIVE_COMPARATOR

Platelets

Intervention Type: OTHER

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

Interventions

Saline

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

Intervention Type: OTHER

Platelets

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Christiana Care Health Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Cipolle

Role: PRINCIPAL_INVESTIGATOR

Christiana Care Health Services

Locations

Christiana Care Health System, Christiana Hospital

Newark, Delaware, United States

Countries

United States

Other Identifiers

31115

Identifier Type: OTHER

Identifier Source: secondary_id

601291

Identifier Type: -

Identifier Source: org_study_id