Evaluation of StablePlateRx in Canine Thrombocytopenic patients

Purpose of Study: 

Effective and available platelet products are lacking in veterinary medicine.  

This study is designed to evaluate the efficacy of a new lyophilized (freeze-dried) platelet product in patients who are experiencing bleeding due to low platelet count (thrombocytopenia).  The study is designed as a randomized clinical trial, and the pets will, by random selection, receive either DMSO cryopreserved (frozen) platelets (the current platelet transfusion product used at ISU), or StablePlate RxTM, the lyophilized platelet product under study. 

StablePlate RxTM is being evaluated for the ability to control life-threatening hemorrhage secondary to thrombocytopenia.

Eligibility: 

If your dog is experiencing critical bleeding due to low platelet numbers, he or she might be eligible for inclusion in the study. 

Client Responsibilities: 

Following determination of eligibility, your dog will be randomized to receive either DMSO-cryopreserved  platelets or StablePlate RxTM in order to stop or slow bleeding. 

During the course of the next 24 hours, 3 blood samples of 5 -10  mL each (approximately 2 teaspoons of blood per draw) will be taken to monitor blood cell counts (including platelet count) and coagulation status of your dog.  Close observation of your dog for a reduction in bleeding severity and for any adverse reactions will occur for the 24 hours after administration of the platelet product. 

Following the 24-hour sample, no further study-related samples will be taken, but a follow-up phone call will be performed by the site coordinator 1 and 2 weeks following the transfusion. 

A Buccal Mucosal Bleeding Time (BMBT) will also be evaluated 3 times in the next 24 hours.  This is a test to determine how well your dog’s platelets stop bleeding.  It involves a small cut being made in your dog’s upper lip (buccal mucosa).  After the cut is made, the time for a clot to form is monitored.  

Client Benefits: 

Your pet may benefit from this study through the transfusion of stored platelet products, which may help to decrease bleeding that is caused by low platelet numbers.  A decrease in bleeding may decrease the number of red blood cell transfusion that your pet requires, and possibly the time that he or she needs to spend in the hospital. 

The cost of the platelet transfusion as well as the associated testing will be borne by the study sponsors, a value of over $1000. 

Contact: 

Dr. Dana N LeVine, 515-294-4900

Dr. Agnes Bourgois-Mochel, 515-291-9866