DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)

Launched by CELLPHIRE THERAPEUTICS, INC. · Jan 12, 2021

Keywords

ClinConnect Summary

The CRYPTICS trial is a clinical study looking at the use of special platelets, which are blood cells that help with clotting, in patients undergoing heart surgery that requires a heart-lung machine (called cardiopulmonary bypass). The study aims to find out if these cryopreserved platelets, which are frozen and stored, work just as well or even better than regular platelets that are stored in liquid form in reducing blood loss during surgery.

To participate in this trial, individuals need to be at least 18 years old and scheduled for heart surgery with specific risk factors for bleeding, such as having multiple heart procedures or needing a long time on the heart-lung machine. Participants will be randomly assigned to receive either the cryopreserved platelets or the liquid stored platelets. All participants will need to provide informed consent and, if applicable, ensure they are not pregnant. This study is currently recruiting and aims to help improve treatment options for patients undergoing cardiac surgeries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female, at least 18 years of age
• 2. Undergoing CPB surgery with at least one risk factor for post-surgical bleeding including:
• • 1. All re-operative cardiac procedures.
• • 2. Expected bypass \> 120 minutes.
• • 3. Any combined cardiac surgery procedures (e.g. multiple valve, valve/CABG).
• • 4. Any procedure that in the estimation of the surgical attending, has a high likelihood of receiving platelets
• • 3. Ability to comprehend and willingness to sign informed consent.
• • 4. If female of childbearing potential, have a negative pregnancy test on the day of the surgery and prior to the surgery agrees to use a method of highly effective birth control from the time of consent through the end of the safety follow-up period (Day 6 or discharge from hospital, whichever is earlier). Note: women must have been surgically sterilized \[bilateral tubal ligation, bilateral oophorectomy, total hysterectomy) or postmenopausal (≥50 years of age and continuous amenorrhea for 24 months) to be considered non-childbearing potential.
• Exclusion Criteria:
• Subjects meeting any of the following criteria will be excluded from the study:
• 1. Undergoing any of the following surgical procedures:
• • 1. Coronary artery bypass surgery alone
• • 2. Implantation of ventricular assist device
• • 3. Thoracoabdominal aortic aneurysm repair
• • 2. Known or suspected pregnancy or breastfeeding
• • 3. History of any major unprovoked thrombotic events
• • 4. History of heparin-inducted thrombocytopenia
• • 5. Active infection treated with antibiotics
• • 6. Refuse transfusion of blood products for religious or other reasons
• • 7. Previous enrollment in this study
• • 8. Immune thrombocytopenic purpura
• • 9. Known allergy to DMSO
• • 10. In the judgement of the investigator, is not a good candidate for the study