DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)

NCT04709705 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: S-16-15
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 16

Brief Summary

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

Keywords

Cryopreserved Platelets

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Secondary Efficacy Endpoint assessed from time zero until the drain tubes are removed or 24 hours post time zero.

  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.

  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

  6 hours intervals through 24 hours post time zero or when chest tubes are removed, whichever is earlier

• Secondary Efficacy Endpoint assessed at the end of first study platelet transfusion through 24-hour post heparin reversal (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)

  Within the 24 hour period after heparin reversal

Study Arms (2)

Cryopreserved platelets

EXPERIMENTAL

Cryopreserved platelets to be given intraoperatively or post operatively up to 3 units post-heparin reversal

Biological: Human platelets

Liquid stored platelets

ACTIVE COMPARATOR

Liquid stored platelets to be given intraoperatively or post operatively up to 3 units post-heparin reversal

Biological: Human platelets

Interventions

Human platelets BIOLOGICAL

Platelets given to control bleeding

Cryopreserved platelets; Liquid stored platelets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Cellphire Therapeutics, Inc.: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (16)

University of Alabama

Birmingham, Alabama, 35205, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

UF Health

Gainesville, Florida, 32608, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

The Ohio State Univ. Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Thomas Jefferson Univ. Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Inova Cardiac Vascular

Falls Church, Virginia, 22042, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, parallel group, active comparator-controlled trial to evaluate the noninferiority or superiority of CPP with LSP in controlling blood loss in patients undergoing CPB surgery.

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: January 14, 2021
• Study Start: October 27, 2021
• Primary Completion: May 8, 2025
• Study Completion: May 8, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)