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

Tracking Information
First Submitted Date ICMJE	November 7, 2012
First Posted Date ICMJE	March 13, 2013
Last Update Posted Date	April 18, 2017
Study Start Date ICMJE	June 2012
Actual Primary Completion Date	April 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 12, 2013)	Hemorrhage growth [ Time Frame: 24 hours ]; Bleeding in the brain will be measured by computerized tomography scan (CT Scan) 24 hours after study treatment is completed.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01810276 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 12, 2013)	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. ]; 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.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE; (submitted: March 12, 2013)	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. ]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 ]Platelet responsiveness will be measured by lab test at 1 and 24 hours post study treatment.
Original Other Outcome Measures ICMJE	Same as current
Descriptive Information
Brief Title ICMJE	Safety of Platelet Transfusion in Patients on Antiplatelet Therapy With Traumatic Head Injury
Official Title ICMJE	The Safety and Efficacy of Platelet Transfusion in Patients Receiving Antiplatelet Therapy That Sustain Traumatic Intracranial Hemorrhage
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.
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 Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Traumatic Head Injury; Intracranial Hemmorhage; Anti-platelet Therapy
Intervention ICMJE	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.
Study Arms	Placebo Comparator: Saline 400 mL of Saline will be given intravenously over 2 hours once. Intervention: Other: Saline; Active Comparator: Platelets 2 apheresis units of platelets (approximately 200 ml) will be given intravenously over 2 hours. Intervention: Other: Platelets
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: March 12, 2013)	40
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	April 2013
Actual Primary Completion Date	April 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01810276
Other Study ID Numbers ICMJE	601291; 31115 ( Other Identifier: Christiana Care Health System )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Christiana Care Health Services
Study Sponsor ICMJE	Christiana Care Health Services
Collaborators ICMJE	United States Department of Defense
Investigators ICMJE	Principal Investigator: Mark Cipolle Christiana Care Health Services
PRS Account	Christiana Care Health Services
Verification Date	April 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP