The Cold-stored Platelet Early Intervention in Traumatic Brain Injury study, or simply CriSP-TBI, is a research study that will look at whether giving early cold-stored platelets to people who have traumatic brain injuries will help stop them from getting worse.
Traumatic brain injury patients normally get platelets—part of the blood that helps clotting—stored at room temperature as part of their care. For this study, some TBI patients in the emergency room will be randomly picked to get cold-stored platelets. Other patients will get the usual care, which could include room temperature platelets. Researchers will also do blood tests and collect information from health records for both groups as part of the study. They will look at both groups of patients and see if one group did better than the other.
What’s different about cold-stored platelets?
The cold-stored platelets used in this study are cooled down soon after being collected and are kept cold until they’re given. They’ve also been stored for longer and are given earlier during treatment than the usual room temperature platelets. New information shows that cold platelets may work better than room temperature platelets at slowing down or stopping brain injuries from getting worse. Researchers think that giving them sooner than normal during treatment might also be helpful.
What are the risks of getting cold-stored platelets? Are there any benefits?
Researchers think that the risks of cold-stored platelets are the same as getting room temperature platelets. These risks are rare and include infection, allergic reaction, fever, and shortness of breath. Researchers don’t know whether getting cold-stored platelets increases your risk for too much clotting. They don’t know whether cold storage makes other risks better or worse, and there may be risks that are not yet known.
Cold-stored platelets are less likely than room temperature to have bacteria that could cause an infection. Researchers think that because cold platelets are more active, they may work better than room temperature at clotting and stopping bleeding at the injury. Giving platelets sooner during treatment may help get bleeding under control faster.
How are people enrolled in the study?
People who have traumatic brain injuries that go to UPMC Presbyterian Emergency Department will be considered for this study.
Normally, researchers must ask a person for their consent before they can be in a study. Because brain injuries must be treated right away, there may not be time to get consent. Giving consent for medical research usually means reading information, talking with doctors and nurses, and having time to think about whether to join. A person with a brain injury are often not able to do these things. Sometimes researchers can talk to the patient’s family to ask for consent. However, in the emergency of a brain injury, the family is often not around or can’t be found before the injured person must be treated. This study could not be done without special permission to include people before getting consent. This permission is called Exception From Informed Consent, or EFIC. Once the enrolled person is better and can consent or their family arrives at the hospital, the researchers will ask for consent to continue with the study. For more information regarding EFIC, please visit [link].
How do I opt out of the study? I don’t want to receive cold-stored platelets.
You can opt-out of the study by contacting us using any of the methods below and letting us know that you do not want to participate. Please make sure to give us your name and contact information so that we can get in touch with you. We can provide you with a hypoallergenic silicone bracelet to wear that indicates that you should not be enrolled into the study. Please note that opting out of the study only means that you will not receive cold-stored platelets as part of the study. Opting out will not prevent you from getting blood products in the hospital as part of your normal care.
For questions or to learn more about this study, please call us at 1-800-664-0557 or email us at CriSP@edc.pitt.edu.