Safety of Platelet Transfusion in Patients on Antiplatelet Therapy With Traumatic Head Injury (PUNCH)
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ClinicalTrials.gov Identifier: NCT01810276 |
Recruitment Status
:
Terminated
(Patient population not available)
First Posted
: March 13, 2013
Last Update Posted
: April 18, 2017
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Tracking Information | ||||
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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 |
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.
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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 |
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.
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE |
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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:
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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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 ) |
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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 |
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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 |