Clinical trial NCT04709705: DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)
Official title: Randomized Controlled Trial Comparing Dimethyl Sulfoxide Cryopreserved Platelets to Liquid Stored Platelets in Patients Undergoing Cardiopulmonary Bypass Surgery (CRYPTICS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Cardiac Surgery
Keywords: Cryopreserved Platelets
Lead sponsor: Cellphire Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2021-01-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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 interim analysis is planned after 150 subjects are treated (75 in each treatment arm) to assess whether the study can be stopped for overwhelming efficacy or if an increase in sample size is warranted to maintain desired conditional power.

Eligibility 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 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

Primary outcomes:
measure: Primary Efficacy Endpoint assessed from time zero until the drain tubes are removed or 24 hours post time zero.
timeFrame: From "time zero" until the drain tubes are removed or 24 hours post time zero, whichever is earlier
Secondary outcomes:
measure: Secondary Efficacy Endpoint assessed from time zero until the drain tubes are removed or 24 hours post time zero.
timeFrame: From "time zero" until the drain tubes are removed or 24 hours post time zero, whichever is earlier
measure: Secondary Efficacy Endpoint assessed at 6 hours interval through 24 hours post time zero or when the chest tubes are removed.
timeFrame: 6 hours intervals through 24 hours post time zero or when chest tubes are removed, whichever is earlier.
measure: Secondary Efficacy Endpoint at 6 hours intervals through 24 hours post time zero or when chest tubes are removed
timeFrame: 6 hours intervals through 24 hours post time zero or when chest tubes are removed, whichever is earlier
measure: Secondary Efficacy Endpoint assessed at the end of first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)
timeFrame: Infused after the end of the first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)
measure: Secondary Efficacy Endpoint assessed within 24 hour post heparin reversal (Efficacy follow-up period)
timeFrame: Within the 24 hour period after heparin reversal
measure: Secondary Efficacy Endpoint assessed from first protamine administration to the time of first suture for incision closure on Day 1 (Day of Surgery)
timeFrame: Time from first protamine administration to the time when the surgeon initiates the first suture for incision closure, Day 1 (Day of operation)
measure: Secondary Efficacy Endpoint assessed at the first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)
timeFrame: Time of first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: District of Columbia
country: United States
facility: George Washington University
state: District of Columbia
city: Gainesville
country: United States
facility: UF Health
state: Florida
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State Univ. Wexner Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: OU Medical Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson Univ. Hospital
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Falls Church
country: United States
facility: Inova Cardiac Vascular
state: Virginia
Study officials:
References: