Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH2090021 | Other Grant/Funding Number | DoD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Utah | OTHER |
| University of Minnesota | OTHER |
| Washington University School of Medicine | OTHER |
| United States Department of Defense |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Room Temperature Platelets | Active Comparator | Platelets stored at 20-24 degrees Celsius |
|
| Cold Stored Platelets | Experimental | Platelets stored at 1-6 degree Celsius |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cold Stored Platelets | Biological | Platelets stored at 1-6 degree Celsius |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Chest tube output | Assessed by volume | 24 hours from first study platelet transfusion or ICU admit (determined from which occurs last) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Total Dose of individual hemostatic adjuncts |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philip C Spinella, MD | University of Pittsburgh | Study Director |
| Marie E Steiner, MD | University of Minnesota | Study Director |
| Nicole D Zantek, MD | University of Minnesota | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | United States | ||
| Banner University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29521797 | Background | 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. | |
| 32902572 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 10, 2024 | Jul 7, 2025 |
Not provided
| FED |
| University of Pittsburgh | OTHER |
Adaptive Design
Not provided
Not provided
Partial Blind
| Room Temperature Platelets |
| Biological |
Platelets stored at 20-24 degrees Celsius |
|
Antifibrinolytic and coagulation factor concentrates
| 24 and 72 hours from start time of first study platelet transfusion |
| Mechanical ventilation | Duration of mechanical ventilation days | up to 28 days after first study platelet transfusion |
| Length of stay | ICU and hospital length of stay | up to 28 days |
| 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 |
| Unplanned sternal closure delay | Sternum left open after cardiac surgery | prior to ICU admission |
| Re-exploration for bleeding | Return to OR after ICU admission | 24 hours first study platelet transfusion |
| Unplanned extracorporeal support post operatively | Placed on ECMO | within 48 hours of first study platelet transfusion |
| 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 |
| Measures of end organ injury | If BUN, creatinine, lactate, troponin, alanine aminotransferase (ALT) are collected clinically. | within 48 hours of first study platelet transfusion |
| Transfusion associated adverse events | As per CDC guidelines | within 7 days of first study platelet transfusion |
| Arterial thrombotic event | Stroke, MI | within 7 days of first study platelet transfusion |
| 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 |
| All cause mortality | Death for any reason | up to 28 days |
| Tucson |
| Arizona |
| 85713 |
| United States |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States |
| University of Florida | Gainesville | Florida | 32608 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Loyola Universtiy Medical Center | Maywood | Illinois | 60153 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66103 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| John Hopkins | Baltimore | Maryland | 21287 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Wake Forest | Winston-Salem | North Carolina | 27157 | United States |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02910 | United States |
| University of Texas Children's Medical Center | Dallas | Texas | 75235 | United States |
| University of Texas Medical Center Clements | Dallas | Texas | 75235 | United States |
| Baylor Texas Children's | Houston | Texas | 77030 | United States |
| Memorial Hermann Texas Medical Center | Houston | Texas | 77030 | United States |
| University of Wisconsin- Madison | Madison | Wisconsin | 53792 | United States |
| Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| 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. |
| 36541257 | Background | 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. |
| 37427705 | Derived | Lewis AR, Peffley N, Klompas AM, Ashrani AA. Role of individual factor X concentrate pharmacokinetic studies in perioperative management of AL amyloidosis-associated acquired factor X deficiency. Transfusion. 2023 Sep;63(9):1773-1777. doi: 10.1111/trf.17477. Epub 2023 Jul 10. |
| 37038736 | Derived | Klompas AM, Stubbs J. Massive transfusion protocol: What's in a name? Transfusion. 2023 Apr;63(4):896-897. doi: 10.1111/trf.17297. No abstract available. |
| ICF_001.pdf |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 30, 2026 | Apr 16, 2026 | 38 | ||
| May 7, 2026 | Jun 2, 2026 | 39 | ||
| Jun 16, 2026 |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided