Cardiac Surgery
Conditions
Keywords
Cryopreserved Platelets
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 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).
Interventions
BIOLOGICALHuman platelets
Platelets given to control bleeding
Sponsors
U.S. Army Medical Research and Development Command
Cellphire Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint assessed from time zero until the drain tubes are removed or 24 hours post time zero. | 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary Efficacy Endpoint assessed at 6 hours interval through 24 hours post time zero or when the chest tubes are removed. | 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. |
| Secondary Efficacy Endpoint at 6 hours intervals through 24 hours post time zero or when chest tubes are removed | 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. |
| Secondary Efficacy Endpoint assessed at the end of first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period) | 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 |
| Secondary Efficacy Endpoint assessed from time zero until the drain tubes are removed or 24 hours post time zero. | 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 |
| Secondary Efficacy Endpoint assessed from first protamine administration to the time of first suture for incision closure on Day 1 (Day of Surgery) | 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) |
| Secondary Efficacy Endpoint assessed at the first study platelet transfusion through 24-hour post heparin reversal (Efficacy follow-up period) | 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)) |
| Secondary Efficacy Endpoint assessed within 24 hour post heparin reversal (Efficacy follow-up period) | 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 |
Countries
United States
Outcome results
None listed