Purpose and Brief Explanation of Study:
The objective of this study is to assess the efficacy of tissue plasminogen activator (TPA) for thrombolysis in feline acute aortic thromboembolism (FATE). The clinical syndrome of aortic thromboembolism (ATE) in cats is initiated by sudden migration of a left atrial thrombus into the systemic arterial system. Treatment options are limited with up to 90% of affected cats euthanatized due to the poor prognosis associated with standard therapies. Indeed, the survival rate for cats hospitalized and treated medically is only 30-40%. Although thrombolytic therapy is the standard of care for acute thrombotic disorders in humans, treatment of feline ATE (FATE) has focused on supportive care. Despite case reports of thrombolytic therapy in cats with FATE, no controlled clinical trials of therapy have been conducted. The study described herein prospectively evaluates the use of TPA in acute FATE.
What qualifies my cat for enrollment in this in this trial?
To participate in this clinical trial your cat must have:
- A diagnosis of ATE affecting at least 2 limbs
- An observed onset of ATE
- Rapid clinical assessment that permits initiation of TPA infusion within 6 hours of the thromboembolic event.
Study exclusion criteria will include:
- Cats moribund at presentation
- ATE affecting all four limbs
- Unstable congestive heart failure or cardiogenic shock
- A patient whose pain cannot be effectively controlled with opiates
- An owner unwilling to cover the initial assessment, or unwilling to hospitalize the cat for at least 48 hours
- Previous use of TPA.
Cats will be randomized to Control (placebo) or Treatment (TPA) group, this means that half of the cats will receive the study drug (TPA) and the other half will not receive the study drug. The doctor making clinical decisions, as well as the owner, will be unaware of the treatment the cat is receiving. The primary treatment outcomes are functional limb score (using a previously-published method) and the proportion of cats discharged at 48 hours for each treatment group. Secondary outcomes are survival to discharge, length of hospitalization, and rate of euthanasia.
The study will cover the admission and initial assessment costs, the study drug and treatment, monitoring and hospitalization up to 48 hours for up to $1700. The study will not be responsible for hospitalization beyond 48 hours, as well as long term complications such as surgery, bandage change, or disposal costs.
For more information regarding this study please contact:
Dr. Julien Guillaumin