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Completed

NCT Number: NCT04709705

DMSO Cryopreserved Platelets in 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.

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Key information

Conditions

Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Alabama, Birmingham, Alabama, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Human platelets

Biological

Platelets given to control bleeding

Primary outcomes

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

    Time frame: From "time zero" until the drain tubes are removed or 24 hours post time zero, whichever is earlier

    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).

Secondary outcomes

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

    Time frame: From "time zero" until the drain tubes are removed or 24 hours post time zero, whichever is earlier

    The primary endpoint given in mL/kg

  2. Secondary Efficacy Endpoint assessed at 6 hours interval through 24 hours post time zero or when the chest tubes are removed.

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

    Chest tube drainage volume (mL) collected at 6 hours intervals through 24 hours post time zero or tube removal, whichever is earlier.

  3. Secondary Efficacy Endpoint at 6 hours intervals through 24 hours post time zero or when chest tubes are removed

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

    Drainage rate (mL/hr) collected at 6 hours intervals through 24 hours post time zero or when chest tube are removed, whichever is earlier.

  4. Secondary Efficacy Endpoint assessed at the end of first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)

    Time frame: Infused after the end of the 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

  5. Secondary Efficacy Endpoint assessed within 24 hour post heparin reversal (Efficacy follow-up period)

    Time frame: Within the 24 hour period after heparin reversal

    Incidence of surgical re-exploration and incidence of verified surgical or other causes for bleeding within the 24 hour period after heparin reversal

  6. Secondary Efficacy Endpoint assessed from first protamine administration to the time of first suture for incision closure on Day 1 (Day of Surgery)

    Time frame: Time from first protamine administration to the time when the surgeon initiates the first suture for incision closure, Day 1 (Day of operation)

    Time to hemostasis (defined as the time from first protamine administration to the time when the surgeon initiates the first suture for incision closure)

  7. Secondary Efficacy Endpoint assessed at the first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)

    Time frame: Time of 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))

Sponsors and collaborators

Lead sponsor

Cellphire Therapeutics, Inc.

Industry

Collaborators

  • U.S. Army Medical Research and Development Command

Registry information

Official study title

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

Acronym: CRYPTICS

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 14, 2021
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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