DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)

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 patients undergoing Cardiopulmonary Bypass Surgery.

Conditions

Cardiac Surgery

Study Overview

Study Details

Study overview

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.

Randomized Controlled Trial Comparing Dimethyl Sulfoxide Cryopreserved Platelets to Liquid Stored Platelets in Patients Undergoing Cardiopulmonary Bypass Surgery (CRYPTICS)

DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)

Condition
Cardiac Surgery
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama, Birmingham, Alabama, United States, 35205

Aurora

University of Colorado, Aurora, Colorado, United States, 80045

Washington

George Washington University, Washington, District of Columbia, United States, 20037

Gainesville

UF Health, Gainesville, Florida, United States, 32608

Portland

Maine Medical Center, Portland, Maine, United States, 04102

Baltimore

University of Maryland Medical Center, Baltimore, Maryland, United States, 21201

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21218

Lebanon

Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States, 03756

Durham

Duke University Hospital, Durham, North Carolina, United States, 27710

Columbus

The Ohio State Univ. Wexner Medical Center, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cellphire Therapeutics, Inc.,

Allan Alexander, MD, STUDY_DIRECTOR, Cellphire Therapeutics, Inc.

Robert Kramer, MD, PRINCIPAL_INVESTIGATOR, MaineHealth

Kenichi Tanaka, MD, PRINCIPAL_INVESTIGATOR, University of Oklahoma

Study Record Dates

2025-02