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

This study has been terminated.
(Patient population not available)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT01810276
First received: November 7, 2012
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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.

Condition Intervention Phase
Traumatic Head Injury
Intracranial Hemmorhage
Anti-platelet Therapy
Other: Saline
Other: Platelets
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Platelet Transfusion in Patients Receiving Antiplatelet Therapy That Sustain Traumatic Intracranial Hemorrhage

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Hemorrhage growth [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 hour and 24 hours post study treatment ] [ Designated as safety issue: No ]
    Platelet responsiveness will be measured by lab test at 1 and 24 hours post study treatment.


Enrollment: 40
Study Start Date: June 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01810276

Locations
United States, Delaware
Christiana Care Health System, Christiana Hospital
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
  More Information

No publications provided

Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT01810276     History of Changes
Other Study ID Numbers: 601291, 31115
Study First Received: November 7, 2012
Last Updated: September 20, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Christiana Care Health Services:
traumatic head injury
intracranial hemorrhage
platelets
anti-platelet therapy
plavix
asprin

Additional relevant MeSH terms:
Craniocerebral Trauma
Intracranial Hemorrhages
Intracranial Hemorrhage, Traumatic
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014