Research project for coagulation in trauma patients

Researchers at the Sunnybrook Research Institute are launching a new research study to find a way to reduce the need for blood transfusions in severely injured patients predicted to require blood transfusions upon arrival to the Sunnybrook Health Sciences Centre emergency department. Barto Nascimento, M.D. with the Department of Surgery at the University of Toronto is the principal investigator for this clinical study.

The purpose of the study is to evaluate the feasibility of rapidly giving RiaSTAP, a human fibrinogen concentrate, to patients requiring blood, before transfusing blood products, which may provide the best outcomes for the trauma patients. If the patient is deemed as requiring blood transfusions, they may be eligible for the study and randomized to receive one of two infusion combinations – RiaSTAP or placebo (inactive, non-medicinal substance). RiaSTAP is currently approved by Health Canada to treat bleeding in people who have a genetic fibrinogen deficiency.

RiaSTAP will be given to half the patients. You will have an equal chance of being placed in either group. The study is a double-blind study, which means that neither you nor your doctor will know if you received RiaSTAP or placebo. In an emergency, the treatment can be identified. Dr. Nascimento and his team will look at the resulting information to see if using RiaSTAP as a first line treatment for bleeding is feasible, and can possibly increase the chances of survival and reduce complications in trauma patients. The knowledge we gain will likely impact the way in which bleeding patients are transfused. It will also inform larger studies assessing whether or not RiaSTAP lowers the amount of otherwise preventable deaths resulting from excessive blood loss.

The trauma surgeon on call in the emergency department will use information obtained from EMS (paramedics) and when a patient arrives to the emergency department to predict if the patient may require transfusion of blood products. The information includes their blood pressure, type of injury, and an ultrasound test to see if they are bleeding in the abdomen.

If the patient is deemed as having or being at risk of a large bleeding, they will be eligible for this study. Then, the blood bank will be notified to randomize (a process like flipping a coin) the patient to receive one of two infusion combinations – RiaSTAP or placebo (inactive, non-medicinal substance). This is the investigational (or research) part of the study. All other treatments will be the same. The study is a double-blind study, which means that neither you nor your doctor will know if you received RiaSTAP or placebo.

The trauma physician will enroll incoming patients who are good candidates for this study. As is common with all treatment of severely injured patients, this study will require the physicians to begin experimental emergency treatment without first obtaining informed consent of the patient or a legal representative and/or family member. All reasonable attempts will be made to contact a family member to discuss this study and obtain their permission for the patient to be in the study. The patient and/or family members can decide at any time to withdraw from the study if they choose. Patients who are enrolled in this study will be closely monitored for the first 24 hours they are in the hospital, frequently during the in hospital stay and contacted after 28 days (if they have been discharged from the hospital) to follow up on how they are doing.

Patients who do not wish to be in this study will be given options for opting out. Anyone who does not wish to be involved in this study should contact Ms. Skeeta Couroux at Sunnybrook Health Sciences Centre and ask for an "opt out" bracelet and wallet card to be sent to them. The "Opt Out" bracelet is a colored, plastic bracelet with the words "NO Fibrinogen In Trauma Trial" on it. If a person has this bracelet or the wallet card when they arrive to the emergency department needing treatment, they will not be screened or enrolled into this study.

Dr. Nascimento and members of the research team will present the project and field questions at a series of meetings with a variety of groups depicted as representatives of Toronto, Canada and surrounding cities and counties. If required, a member of the Sunnybrook Research Ethics Board will also attend the meetings to assist in answering any questions related to emergency consent issues, etc. Upon completion of the community consultation meetings, Dr. Nascimento's team will report back to Sunnybrook Research Ethics Board, which will determine whether the Sunnybrook Health Sciences Centre will proceed with the clinical trial.

Contact Information

If you would like to schedule a community consultation meeting or would like more information, please contact:
Ms. Skeeta Couroux 416-480-6100 ext. 67322