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Trial record 3 of 5 for:    Cellphire

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

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ClinicalTrials.gov Identifier: NCT04709705
Recruitment Status : Not yet recruiting
First Posted : January 14, 2021
Last Update Posted : January 15, 2021
Sponsor:
Collaborator:
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
Cellphire, Inc.

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.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Biological: Human platelets Phase 2 Phase 3

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 using clinical site and presence of an underlying congenital or acquired hypercoagulable state as a stratification variable 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 of 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Dimethyl Sulfoxide Cryopreserved Platelets to Liquid Stored Platelets in Patients Undergoing Cardiopulmonary Bypass Surgery (CRYPTICS)
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : October 2022

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




Primary Outcome Measures :
  1. Primary Efficacy Endpoint assessed from the time the mediastinal and pleural chest tubes are inserted at the end of operation until the drain tubes are removed or 24 hours after chest tube insertion [ Time Frame: From the time the mediastinal and pleural chest tubes are inserted at the end of operation until the drain tubes are removed or 24 hours after chest tube insertion, whichever is earlier ]
    Total volume of chest tube drainage assessed by measurement of the volume of blood collected from the mediastinal and pleural drains inserted at the end of the operation until the time the drain tubes are removed or 24 hours after chest tube insertion, whichever is earlier.


Secondary Outcome Measures :
  1. Secondary Efficacy Endpoint assessed from the time the mediastinal and pleural chest tubes are inserted at the end of operation until the drain tubes are removed or 24 hours after chest tube insertion [ Time Frame: From the time the mediastinal and pleural chest tubes are inserted at the end of operation until the drain tubes are removed or 24 hours after chest tube insertion, whichever is earlier ]
    The primary endpoint given in mL/kg

  2. Secondary Efficacy Endpoint assessed at 6 hours interval through 24 hours after chest tube insertion or when the chest tubes are removed [ Time Frame: 6 hours intervals through 24 hours after chest tubes insertion or when chest tubes are removed, whichever is earlier ]
    Chest tube drainage volume (mL) collected at 6 hours intervals through 24 hours after chest tube insertion or tube removal, whichever is earlier.

  3. Secondary Efficacy Endpoint at 6 hours intervals through 24 hours after chest tube insertion or when chest tubes are removed [ Time Frame: 6 hours intervals through 24 hours after chest tube insertion or when chest tubes are removed, whichever is earlier ]
    Drainage rate (mL/hr) collected at 6 hours intervals through 24 hours after chest tube insertion 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 protamine administration to the time of first suture for incision closure on Day 1 (Day of Surgery) [ Time Frame: Time from 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 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 LSP)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 intrathoracic procedure (with bypass) confined to the chest, except those specifically excluded.
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04709705


Contacts
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Contact: Ganiat Idris, BA 2128106499 ganiat.idris@avaniaclinical.com

Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21218
Contact: Judi Willhide, RN, CCRP    410-955-3597    jwillhi3@jhmi.edu   
Sponsors and Collaborators
Cellphire, Inc.
U.S. Army Medical Research and Development Command
Investigators
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Study Director: Mike Fitzpatrick, PhD Cellphire, Inc.
Principal Investigator: Glenn Whitman, MD Johns Hopkins University
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Responsible Party: Cellphire, Inc.
ClinicalTrials.gov Identifier: NCT04709705    
Other Study ID Numbers: S-16-15
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cellphire, Inc.:
Cryopreserved Platelets