Acute Blood Loss Clinical Trial
— CHIPSOfficial title:
CHIlled Platelet Study
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.
| Status | Recruiting |
| Enrollment | 1000 |
| Est. completion date | January 31, 2025 |
| Est. primary completion date | January 1, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 0 Days to 84 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Fiona Stanley Hospital | Murdoch | Western Australia |
| Australia | Sir Charles Gairdner Hospital | Nedlands | Western Australia |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | John Hopkins | Baltimore | Maryland |
| United States | Northwestern Memorial Hospital | Chicago | Illinois |
| United States | Cincinnati Children's Hospital | Cincinnati | Ohio |
| United States | University of Texas Children's Medical Center | Dallas | Texas |
| United States | University of Texas Medical Center Clements | Dallas | Texas |
| United States | University of Florida | Gainesville | Florida |
| United States | Baylor Texas Children's | Houston | Texas |
| United States | Memorial Hermann Texas Medical Center | Houston | Texas |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | University of Kentucky | Lexington | Kentucky |
| United States | Ronald Reagan UCLA Medical Center | Los Angeles | California |
| United States | University of Wisconsin- Madison | Madison | Wisconsin |
| United States | Loyola Universtiy Medical Center | Maywood | Illinois |
| United States | Aurora St. Luke's Medical Center | Milwaukee | Wisconsin |
| United States | Children's Hospital of Wisconsin | Milwaukee | Wisconsin |
| United States | University of Minnesota | Minneapolis | Minnesota |
| United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
| United States | Mayo Clinic Arizona | Phoenix | Arizona |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | Oregon Health and Science University | Portland | Oregon |
| United States | Rhode Island Hospital | Providence | Rhode Island |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Banner University Medical Center | Tucson | Arizona |
| United States | Wake Forest | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Philip Spinella | United States Department of Defense, University of Minnesota, University of Pittsburgh, University of Utah, Washington University School of Medicine |
United States, Australia,
Krachey E, Viele K, Spinella PC, Steiner ME, Zantek ND, Lewis RJ. The design of an adaptive clinical trial to evaluate the efficacy of platelets stored at low temperature in surgical patients. J Trauma Acute Care Surg. 2018 Jun;84(6S Suppl 1):S41-S46. doi: 10.1097/TA.0000000000001876. — View Citation
Strandenes G, Sivertsen J, Bjerkvig CK, Fosse TK, Cap AP, Del Junco DJ, Kristoffersen EK, Haaverstad R, Kvalheim V, Braathen H, Lunde THF, Hervig T, Hufthammer KO, Spinella PC, Apelseth TO. A Pilot Trial of Platelets Stored Cold versus at Room Temperature for Complex Cardiothoracic Surgery. Anesthesiology. 2020 Dec 1;133(6):1173-1183. doi: 10.1097/ALN.0000000000003550. — View Citation
Zantek ND, Steiner ME, VanBuren JM, Lewis RJ, Berry NS, Viele K, Krachey E, Dean JM, Nelson S, Spinella PC. Design and logistical considerations for the randomized adaptive non-inferiority storage-duration-ranging CHIlled Platelet Study. Clin Trials. 2023 Feb;20(1):36-46. doi: 10.1177/17407745221126423. Epub 2022 Dec 21. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Blood product administration | The quantity of RBCs, Plasma, Platelets, Cryoprecipitate, and Whole blood | 24 and 72 hours from start time of first study platelet transfusion | |
| Other | Total Dose of individual hemostatic adjuncts | Antifibrinolytic and coagulation factor concentrates | 24 and 72 hours from start time of first study platelet transfusion | |
| Other | Mechanical ventilation | Duration of mechanical ventilation days | up to 28 days after first study platelet transfusion | |
| Other | Length of stay | ICU and hospital length of stay | up to 28 days | |
| Other | Relative change in hemostatic parameters | CBC (platelet count and hemoglobin), PT/INR, PTT, fibrinogen, and TEG | 6 and 24 hours after first study platelet transfusion | |
| Other | Unplanned sternal closure delay | Sternum left open after cardiac surgery | prior to ICU admission | |
| Other | Re-exploration for bleeding | Return to OR after ICU admission | 24 hours first study platelet transfusion | |
| Other | Unplanned extracorporeal support post operatively | Placed on ECMO | within 48 hours of first study platelet transfusion | |
| Other | Morbidities after ICU admission | Acute respiratory distress syndrome, need for and duration of renal support, renal failure, septic shock | within 7 days of first study platelet transfusion | |
| Other | Measures of end organ injury | If BUN, creatinine, lactate, troponin, alanine aminotransferase (ALT) are collected clinically. | within 48 hours of first study platelet transfusion | |
| Other | Transfusion associated adverse events | As per CDC guidelines | within 7 days of first study platelet transfusion | |
| Other | Arterial thrombotic event | Stroke, MI | within 7 days of first study platelet transfusion | |
| Other | Venous thrombotic event | Deep vein thrombosis or pulmonary embolism confirmed by ultrasound, venography, perfusion scan, spiral CT, MRI, or pulmonary angiogram | within 7 days of first study platelet transfusion | |
| Other | All cause mortality | Death for any reason | up to 28 days | |
| Primary | Hemostatic efficacy | Assessed by a bleeding score, a modified Peri-Operative bleeding score: the score ranges from 1-5. A lower score signifies a better outcome. | 24 hours after first study platelet transfusion | |
| Secondary | Chest tube output | Assessed by volume | 24 hours from first study platelet transfusion or ICU admit (determined from which occurs last) |