DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)

Cellphire Therapeutics

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cardiac Surgery

Treatments: Biological: Human platelets

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT04709705

S-16-15

Details and patient eligibility

About

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.

Full 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 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).

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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161 participants in 2 patient groups

Cryopreserved platelets

Experimental group

Description:

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

Treatment:

Biological: Human platelets

Liquid stored platelets

Active Comparator group

Description:

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

Treatment:

Biological: Human platelets