Using Cryopreserved Platelets in Heart Surgery

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

This study is testing whether using frozen platelets instead of fresh ones can help heart surgery patients who are at risk of heavy bleeding during their operation.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cellphire Therapeutics, Inc. (Industry-sponsored)
• Locations: 16 sites (Birmingham, Alabama and 15 other locations)
• Trial ID: NCT04709705 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of Cryopreserved Platelets compared to Liquid Stored Platelets in controlling blood loss during Cardiopulmonary Bypass Surgery. Patients who are at risk for significant bleeding post-surgery will be randomly assigned to receive one of the two types of platelets. The study aims to determine if Cryopreserved Platelets are non-inferior or superior in managing bleeding. An interim analysis will be conducted after 150 subjects to assess the efficacy of the treatments.

Who should consider this trial

Good fit: Ideal candidates are adults undergoing Cardiopulmonary Bypass Surgery with risk factors for post-surgical bleeding.

Not a fit: Patients not undergoing Cardiopulmonary Bypass Surgery or those without risk factors for bleeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved blood management and reduced complications in cardiac surgery patients.

How similar studies have performed: Other studies have explored the use of cryopreserved platelets, but this specific approach in cardiac surgery is relatively novel.

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

Where this trial is running

Birmingham, Alabama and 15 other locations

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

Study contacts

• Study coordinator: Anna Yu

Conditions Cardiac Surgery; Cryopreserved Platelets