DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)

Completed · Phase 2/Phase 3

Conditions studied: Cardiac Surgery

In brief

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.

Key facts

Study ID

NCT04709705

Run by

Cellphire Therapeutics, Inc.

People needed

161

Starts

2021-10-27

Expected to finish

2025-05-08

Last updated by the study team

2025-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• University of Colorado — Aurora, Colorado, United States
• George Washington University — Washington D.C., District of Columbia, United States
• UF Health — Gainesville, Florida, United States
• Maine Medical Center — Portland, Maine, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Duke University Hospital — Durham, North Carolina, United States
• The Ohio State Univ. Wexner Medical Center — Columbus, Ohio, United States
• OU Medical Center — Oklahoma City, Oklahoma, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Abington Memorial Hospital — Abington, Pennsylvania, United States
• Thomas Jefferson Univ. Hospital — Philadelphia, Pennsylvania, United States
• University of Virginia Medical Center — Charlottesville, Virginia, United States
• Inova Cardiac Vascular — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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