Randomized Controlled Trial Comparing Dimethyl Sulfoxide Cryopreserved Platelets to Liquid Stored Platelets in Patients Undergoing Cardiopulmonary Bypass Surgery (CRYPTICS)
Protocol Number: S-16-15
Protocol Version: Version 6.0
Version Date: 14 Jul 2022
Study Investigators
- PI: Gage Parr, MD
- Sub-I: Danielle Davison, MD
- Sub-I: Farzad Najam, MD
- Sub-I: Xiomara Fernandez, MD
Study Objectives
The primary objective of this study is to compare the volume of blood loss [hereafter termed “total chest tube drainage” (CTD)] in patients undergoing cardiopulmonary bypass (CPB) surgery from the time the mediastinal and pleural chest tubes are inserted, chest closed and attached to suction at the end of surgery until the time the chest tubes are removed or 24 hours after chest closure and attachment to suction, whichever is earlier, between patients who received CPP (Cryo Preserved Platelets) and those who received standard liquid stored platelets (LSP). The time point at 24 hours post chest closure and attachment to suction or when chest tubes are removed is considered the end of the efficacy follow-up period. It is hypothesized that the total volume of CTD in subjects receiving CPP will be non-inferior to or significantly less than the amount in subjects who received LSP. A 2-stage analysis will test first if the CTD is non-inferior between groups, then if non-inferiority is shown, superiority of CPP over LSP will be tested.
Patient Population
See inclusion criteria below.
Inclusion Criteria
- Male or female, at least 18 years of age
- Undergoing any intrathoracic surgical procedure confined to the chest necessitating cardiopulmonary bypass 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).
- Ability to comprehend and willingness to sign informed consent per local site policy.
- 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:
- Isolated coronary artery bypass surgery
- 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 judgment of the investigator, is not a good candidate for the study