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Clinical Trials Resource Center

CriSP-HS Trial

Informed consent is the process where the researchers share key facts about a research study with a person to help them decide whether or not to take part in the research study. Taking part in research is voluntary and people have the right to refuse to take part in a research study. In some emergency situations, people who are taking part in a research study are not able to give their consent due to their condition. The Cold-stored Platelet Early Intervention in Hemorrhagic Shock study, or simply CriSP-HS, is a research study that will look at whether giving early cold-stored platelets to people who have injuries that cause a lot of blood loss will help them survive better than standard care.

What is the purpose of this research study?
Normally when a person loses a lot of blood, they are given the different parts that make up blood, including room temperature platelets. Platelets are the part of blood that help clotting. For this study, some people in the Emergency Room who have injuries that caused them to lose a lot of blood will be randomly picked to get cold-stored platelets. The other people will get the usual care, which could include room temperature platelets. Information from health records for both groups will also be collected as part of the study. Researchers 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’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 stopping bleeding.  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?
Several hospitals across the country will be participating in this research including two centers at the Texas Medical Center in Houston. People who have traumatic injuries and resulting blood loss that go to one of these two Emergency Departments will be considered for this study.

UTHealth and Memorial Hermann Hospital - Texas Medical Center
Baylor College of Medicine and Ben Taub Hospital- Harris Health.

Normally, researchers must ask a person for their consent before they can be in a study. Because people losing blood 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 injuries causing them to lose a lot of blood 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 stopping bleeding, 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 the UTHealth page on Planned Emergency Research

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 emailing us at clinicaltrials@uth.tmc.edu or calling us at 1-800-664-0557 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.