DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS) (NCT04709705) | Clinical Trial Compass
CompletedPhase 2/3
DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)
United States161 participantsStarted 2021-10-27
Plain-language 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 patients undergoing Cardiopulmonary Bypass Surgery.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Undergoing any of the following surgical procedures:
✕. Coronary artery bypass surgery alone
✕. Implantation of ventricular assist device
✕
What they're measuring
1
Primary Efficacy Endpoint assessed from time zero until the drain tubes are removed or 24 hours post time zero.
Timeframe: From "time zero" until the drain tubes are removed or 24 hours post time zero, whichever is earlier