Status:
COMPLETED
DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)
Lead Sponsor:
Cellphire Therapeutics, Inc.
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Conditions:
Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
A randomized, parallel group, active comparator-controlled trial to evaluate the non-inferiority or superiority of Cryopreserved Platelets with Liquid Stored Platelets in controlling blood loss in pat...
Detailed Description
A randomized, parallel group, active comparator-controlled trial to evaluate the non-inferiority or superiority of Cryopreserved Platelets with Liquid Stored Platelets in controlling blood loss in pat...
Eligibility Criteria
Inclusion
- Male or female, at least 18 years of age
- Undergoing CPB surgery with at least one risk factor for post-surgical bleeding including:
- All re-operative cardiac procedures.
- Expected bypass \> 120 minutes.
- Any combined cardiac surgery procedures (e.g. multiple valve, valve/CABG).
- Any procedure that in the estimation of the surgical attending, has a high likelihood of receiving platelets
- Ability to comprehend and willingness to sign informed consent.
- 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
- Subjects meeting any of the following criteria will be excluded from the study:
- Undergoing any of the following surgical procedures:
- Coronary artery bypass surgery alone
- Implantation of ventricular assist device
- Thoracoabdominal aortic aneurysm repair
- Known or suspected pregnancy or breastfeeding
- History of any major unprovoked thrombotic events
- History of heparin-inducted thrombocytopenia
- Active infection treated with antibiotics
- Refuse transfusion of blood products for religious or other reasons
- Previous enrollment in this study
- Immune thrombocytopenic purpura
- Known allergy to DMSO
- In the judgement of the investigator, is not a good candidate for the study
Key Trial Info
Start Date :
October 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2025
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT04709705
Start Date
October 27 2021
End Date
May 8 2025
Last Update
October 1 2025
Active Locations (16)
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1
University of Alabama
Birmingham, Alabama, United States, 35205
2
University of Colorado
Aurora, Colorado, United States, 80045
3
George Washington University
Washington D.C., District of Columbia, United States, 20037
4
UF Health
Gainesville, Florida, United States, 32608