An interventional study of Saline and Platelets in Traumatic Head Injury, Intracranial Hemmorhage and Anti-platelet Therapy, sponsored by Christiana Care Health Services. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-18.
Sponsored by Christiana Care Health Services · Not applicable, Interventional, and Treatment
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:
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.
253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 137 interventional studies indexed under Craniocerebral Trauma.
Browse Craniocerebral Trauma studies →Christiana Care Health Services is the lead sponsor of 94 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
400 mL of Saline will be given intravenously over 2 hours once.
Other: Saline
2 apheresis units of platelets (approximately 200 ml) will be given intravenously over 2 hours.
Other: Platelets
400 mL of Saline will be given intravenously over 2 hours once
2 apheresis units of platelets (approximately 200 ml) will be given intravenously over 2 hours.
Hemorrhage growth
Bleeding in the brain will be measured by computerized tomography scan (CT Scan) 24 hours after study treatment is completed.
Time frame: 24 hours
Neurological Outcome
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.
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.
Thromboembolic complications
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.
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.
Platelet responsiveness
Platelet responsiveness will be measured by lab test at 1 and 24 hours post study treatment.
Time frame: 1 hour and 24 hours post study treatment
This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Christiana Care Health Services