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

NCT01810276 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-04-18

No results posted yet for this study

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.

Conditions

  • Traumatic Head Injury
  • Intracranial Hemmorhage
  • Anti-platelet Therapy

Interventions

OTHER

Saline

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

OTHER

Platelets

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

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Christiana Care Health Services

    lead OTHER

Principal Investigators

  • Mark Cipolle · Christiana Care Health Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01810276 on ClinicalTrials.gov