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. People who have traumatic brain injuries normally get platelets that are room temperature as part of their care. For this study, some peo
ple in the Emergency Room who have traumatic brain injuries will be randomly picked to get cold-stored platelets. The other people will get the usual care, which could include room temperature platelets. Researchers will also do some blood tests and collect information from health records for both groups as part of the study. They will look at both groups of people 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 are given. They have 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. Who will be included? People who are over 18 years old and under 90 years old with:
• Blunt closed head injury
• A need for platelet transfusion
• A history of taking anti-platelet medication regularly
People who meet the entry criteria will be randomly entered, like flipping a coin, into one of the two study groups:
• Those who get an early infusion of urgent release cold stored platelets.
• Those who get room temperature platelet transfusion per standard care. What are the risks? 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. What are the benefits? Because we do not know which treatment is best for treating TBI, a person enrolled in the study may benefit from being placed in one study group over the other. Based on the information we get from this study, people who have a TBI in the future may benefit from what is learned from this study. 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 is enrollment in CriSP-TBI different from other studies? 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. When consent is not possible, a person might be enrolled in this study without consent. This is called “Exception from Informed Consent” (EFIC). Once the family or legal representative is located, they will be asked whether they want the participant to continue in the study. What is EFIC? Exception from informed consent (EFIC) for emergency research refers to a special set of rules used by the US government to regulate studies when research participants cannot tell researchers their desires in a medical emergency. These special rules allow research studies in certain emergency situations to be conducted without consent. EFIC can only be used when:
• The person’s life is at risk, AND,
• The best treatment is not known, AND
• The study might help the person, AND
• It is not possible to get permission:
o from the person because of his or her medical condition nor
o from the person’s representative because there is a very short amount of time required to treat the medical problem, or the representative is not available. How can I share my opinions about this study? Before the study starts, meetings will be held in the community to provide information, answer questions, and get community members’ thoughts and feelings about the study. You can call the study team to complete a one-on-one interview or survey about the study. There will also be information about the study in the media (for example, newspapers, TV and radio). 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.
