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

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

Study Description

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).

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

• Study Director: Mike Fitzpatrick, PhD; Cellphire, Inc.
• Principal Investigator: Glenn Whitman, MD; Johns Hopkins University

More Information

• Responsible Party: Cellphire, Inc.
• ClinicalTrials.gov Identifier: NCT04709705
• Other Study ID Numbers: S-16-15
• First Posted: January 14, 2021
• Last Update Posted: January 15, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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