*ON HOLD* Using a New Drug to Treat Dogs with Excessive Bleeding due to Trauma
This trial is currently on hold
The Cornell University Hospital for Animals (CUHA) along with NC State Veterinary Hospital is recruiting severely injured dogs for enrollment in a clinical trial testing a clot-stabilizing drug called tranexamic acid (TXA). In humans, early administration of TXA following trauma significantly reduces mortality and risk of death from hemorrhage. The drug works by blocking natural process clot breakdown (fibrinolysis). In health, fibrinolysis is essential for maintaining the normal balance between clotting and bleeding. However, this process becomes unbalanced after trauma and can lead to excessive clot breakdown which is associated with continued bleeding, need for massive blood transfusions, and increased risk of death. The objective of this study is to determine the efficacy of a proposed TXA treatment protocol to reverse fibrinolysis in dogs with hemorrhagic shock due to trauma. This will be the first prospective evaluation of clinical efficacy of tranexamic acid in the dog following trauma and is funded by the United States Special Operations Command to advance trauma care for military dogs.
GOALS OF THE STUDY: The small amount of blood collected during this double-blinded study will be used to provide information to help explain the mechanism behind TXA action in trauma. This information is currently lacking in human studies reporting the survival advantage in people given TXA after trauma. Both human and veterinary trauma practitioners, whether military or civilian, will benefit from this contribution to an under explored area. For our military, the greatest impact of this study is the potential preservation of life operational utility of canine force-multipliers following trauma while simultaneously improving our understanding of the mechanism of hemostatic action of TXA.
ELIGIBILITY: Dogs between 8 and 160 pounds with a recent trauma, shock, and evidence of significant hemorrhage on presentation will be eligible for inclusion. Dogs must arrive to CUHA within 3 hours of the injury and must have excessive fibrinolysis at the time of admission (will be checked at CUHA via thromboelastography (TEG)). Dogs with a history of documented thromboembolic disease, those who have received an anticoagulant or antiplatelet drug therapy in the past 2 weeks, or those who have had an administration of any synthetic colloid such as Vetastarch™ or hetastarch will not be eligible to enroll.
COMPENSATION: For participation in the study, owners of eligible dogs will receive a $2,500 credit towards the cost of their care at CUHA.
OWNER RESPONSIBILITIES/EXPECTATIONS FOR THE DAY: Your only responsibility is to bring your dog to CUHA for emergency treatment. Dogs presented for care will be immediately assessed and treated for their injuries and shock. During initial stabilization we will confirm that they have had significant blood loss and test for the presence of excess fibrinolysis, a common complication of severe traumatic injuries. Dogs with clotting disorders will be randomized to treatment with either tranexamic acid or saline placebo, in addition to all necessary care to stabilize them and care for their wounds. Blood will be drawn from a sampling line three times over 24 hours.
CONTACT/SCHEDULE AN APPOINTMENT: For questions about the study (not for emergencies) email email@example.com. For emergencies please call 607.253.3060 to inform the Emergency and Critical Care section of a potential patient with trauma arriving.
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