DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS) (CRYPTICS)

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Biological: Human platelets

Detailed 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. Patients planning to undergo Cardiopulmonary Bypass Surgery with risk factors for significant bleeding post-surgery will be approached. Subjects will be randomized in a 1:1 ratio to receive either Cryopreserved Platelets or Liquid Stored Platelets. Eligible subjects will undergo Cardiopulmonary Bypass Surgery and at the completion of bypass and heparin reversal subjects will likely be assessed for eligibility before coming off bypass. Study platelets will be given either intraoperatively after heparin reversal and return of active clotting time (ACT) to < 140 sec or post operatively (after chest closure).

A single unblinded interim analysis on the primary efficacy endpoint will be performed for this study after 75% of the planned number of mITT subjects are treated (i.e., after 150 mITT subjects are treated, irrespective of the number of subjects in each treatment group).

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • University of Alabama
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
      • George Washington University
  • Florida
    • Gainesville, Florida, United States, 32608
      • UF Health
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
    • Baltimore, Maryland, United States, 21218
      • Johns Hopkins University
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State Univ. Wexner Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • OU Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Memorial Hospital
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson Univ. Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Medical Center
    • Falls Church, Virginia, United States, 22042
      • Inova Cardiac Vascular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cryopreserved platelets; Cryopreserved platelets to be given intraoperatively or post operatively up to 3 units post-heparin reversal	Biological: Human platelets; Platelets given to control bleeding
Active Comparator: Liquid stored platelets; Liquid stored platelets to be given intraoperatively or post operatively up to 3 units post-heparin reversal	Biological: Human platelets; Platelets given to control bleeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy Endpoint assessed from time zero until the drain tubes are removed or 24 hours post time zero.	Total volume of chest tube drainage assessed by measurement of the volume of blood collected from the mediastinal and pleural drains from "time zero", the time of 1) chest closure or equivalent, 2) chest tubes or equivalent are attached to a graduated post drainage system, and 3) with suction (defined as time zero for analytical purposes) determined in mL/kg every hour during the first 12 hours and at 6-hour intervals thereafter, for up to 24 hours or chest tube removal (whichever is earlier).	From "time zero" until the drain tubes are removed or 24 hours post time zero, whichever is earlier

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Efficacy Endpoint assessed at the end of first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)	Total units by type of other post-operative blood products (pRBC, non-study platelets, CRYO, plasma, clotting factor concentrates) infused after the end of the first study platelet transfusion until end of the efficacy follow-up period	Infused after the end of the first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)
Secondary Efficacy Endpoint assessed within 24 hour post heparin reversal (Efficacy follow-up period)	Incidence of surgical re-exploration and incidence of verified surgical or other causes for bleeding within the 24 hour period after heparin reversal	Within the 24 hour period after heparin reversal
Secondary Efficacy Endpoint assessed from time zero until the drain tubes are removed or 24 hours post time zero.	The primary endpoint given in mL/kg	From "time zero" until the drain tubes are removed or 24 hours post time zero, whichever is earlier
Secondary Efficacy Endpoint assessed at 6 hours interval through 24 hours post time zero or when the chest tubes are removed.	Chest tube drainage volume (mL) collected at 6 hours intervals through 24 hours post time zero or tube removal, whichever is earlier.	6 hours intervals through 24 hours post time zero or when chest tubes are removed, whichever is earlier.
Secondary Efficacy Endpoint at 6 hours intervals through 24 hours post time zero or when chest tubes are removed	Drainage rate (mL/hr) collected at 6 hours intervals through 24 hours post time zero or when chest tube are removed, whichever is earlier.	6 hours intervals through 24 hours post time zero or when chest tubes are removed, whichever is earlier
Secondary Efficacy Endpoint assessed from first protamine administration to the time of first suture for incision closure on Day 1 (Day of Surgery)	Time to hemostasis (defined as the time from first protamine administration to the time when the surgeon initiates the first suture for incision closure)	Time from first protamine administration to the time when the surgeon initiates the first suture for incision closure, Day 1 (Day of operation)
Secondary Efficacy Endpoint assessed at the first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)	Treatment failure (defined as requiring more than three units of study treatment (CPP or LSP))	Time of first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)

Collaborators and Investigators

• Sponsor: Cellphire Therapeutics, Inc.
• Collaborators: U.S. Army Medical Research and Development Command
• Investigators: Study Director: Allan Alexander, MD, Cellphire Therapeutics, Inc.; Principal Investigator: Robert Kramer, MD, MaineHealth; Principal Investigator: Kenichi Tanaka, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2021
• Primary Completion (Actual): May 8, 2025
• Study Completion (Actual): May 8, 2025

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Cryopreserved Platelets
• Other Study ID Numbers: S-16-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No