CriSP-HS

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. People who have traumatic injuries and resulting blood loss that go to a participating hospital’s 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 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 www.litesnetwork.org/projects/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 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.