Acute Blood Loss
Conditions
Keywords
platelets, cold-stored platelets, bleeding, hemostasis, complex cardiac surgery
Brief summary
A phase 3 randomized partial blind storage duration ranging study in patients undergoing complex cardiac surgery that will compare the transfusion of cold stored platelets to standard room temperature stored platelets. The primary objective is to establish that cold stored platelets have a non-inferiority (or superiority) to room temperature platelets.
Interventions
BIOLOGICALCold Stored Platelets
Platelets stored at 1-6 degree Celsius
BIOLOGICALRoom Temperature Platelets
Platelets stored at 20-24 degrees Celsius
Sponsors
University of Utah
University of Minnesota
Washington University School of Medicine
United States Department of Defense
University of Pittsburgh
Philip Spinella
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Partial Blind
Intervention model description
Adaptive Design
Eligibility
Sex/Gender
ALL
Age
0 Days to 84 Years
Healthy volunteers
No
Inclusion criteria
* Viable neonates ≥ 3 kg at time of enrollment (as defined in Section 4.1) OR age greater than 28 days and less than 85 years of age at time of consent; AND * Planned complex cardiac surgery with planned use of cardiopulmonary bypass, with an expectation of bleeding requiring platelet transfusion.
Exclusion criteria
* Expected order for washed or volume reduced platelets * Patient with known anti-platelet antibodies * Platelet transfusion refractoriness due to anti-HLA antibodies * Known or suspected pregnancy * Previously randomized in this study * Conscious objection or unwillingness to receive blood products * Known IgA deficiency * Known congenital platelet disorder * Known congenital bleeding disorder * Planned post-operative extracorporeal membrane oxygenation (ECMO), ventricular assist device (VAD), and/or continuous renal replacement therapy (CRRT)/ hemodialysis * Patients intended to receive whole blood either intra-operative or post-operative for bleeding * Platelet transfusion (of any type) within 24 hours prior to the date of surgery * Pre-operative thrombocytopenia, defined as platelet count \<75x10(9)/L, based on the most recent labs completed within 72 hours prior to the date of surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemostatic efficacy | 24 hours after first study platelet transfusion | Assessed by a bleeding score, a modified Peri-Operative bleeding score: the score ranges from 1-5. A lower score signifies a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chest tube output | 24 hours from first study platelet transfusion or ICU admit (determined from which occurs last) | Assessed by volume |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total Dose of individual hemostatic adjuncts | 24 and 72 hours from start time of first study platelet transfusion | Antifibrinolytic and coagulation factor concentrates |
| Mechanical ventilation | up to 28 days after first study platelet transfusion | Duration of mechanical ventilation days |
| Length of stay | up to 28 days | ICU and hospital length of stay |
| Relative change in hemostatic parameters | 6 and 24 hours after first study platelet transfusion | CBC (platelet count and hemoglobin), PT/INR, PTT, fibrinogen, and TEG |
| Re-exploration for bleeding | 24 hours first study platelet transfusion | Return to OR after ICU admission |
| Unplanned extracorporeal support post operatively | within 48 hours of first study platelet transfusion | Placed on ECMO |
| Unplanned sternal closure delay | prior to ICU admission | Sternum left open after cardiac surgery |
| Measures of end organ injury | within 48 hours of first study platelet transfusion | If BUN, creatinine, lactate, troponin, alanine aminotransferase (ALT) are collected clinically. |
| Transfusion associated adverse events | within 7 days of first study platelet transfusion | As per CDC guidelines |
| Arterial thrombotic event | within 7 days of first study platelet transfusion | Stroke, MI |
| Venous thrombotic event | within 7 days of first study platelet transfusion | Deep vein thrombosis or pulmonary embolism confirmed by ultrasound, venography, perfusion scan, spiral CT, MRI, or pulmonary angiogram |
| All cause mortality | up to 28 days | Death for any reason |
| Morbidities after ICU admission | within 7 days of first study platelet transfusion | Acute respiratory distress syndrome, need for and duration of renal support, renal failure, septic shock |
| Blood product administration | 24 and 72 hours from start time of first study platelet transfusion | The quantity of RBCs, Plasma, Platelets, Cryoprecipitate, and Whole blood |
Countries
Australia, United States
Outcome results
None listed