Trauma Clinical Trial
Official title:
At What Point is Blood Transfusion Futile in Trauma?: A Retrospective Study of Ultra Massive Transfusion Protocol in Adult Trauma Patients Undergoing Surgery Within 24 Hours and Effects on Mortality and Clinical Outcomes
Verified date | March 2024 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to determine the effects of ultraMTP (>/=30 units pRBC within 24 hours) in trauma patients on mortality and secondary outcomes. The aim is to determine if there is a set number of pRBC units transfused in adult trauma patients undergoing surgery within 24 hours, after which mortality is inevitable and further transfusions are futile.
Status | Completed |
Enrollment | 3000 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - >/= 18 years old - trauma patient - undergoing surgery within first 24 hours of admission - received blood products within 24 hours of admission Exclusion Criteria: - <18-years-old - no surgery within the first 24 hours - did not receive blood products within the first 24 hours |
Country | Name | City | State |
---|---|---|---|
United States | Keck School of Medicine of the University of Southern California | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | Medical College of Wisconsin, Tulane University School of Medicine, University of Arkansas, University of California, Davis, University of California, Irvine, University of Chicago, University of Miami, University of Texas |
United States,
Charles A, Shaikh AA, Walters M, Huehl S, Pomerantz R. Blood transfusion is an independent predictor of mortality after blunt trauma. Am Surg. 2007 Jan;73(1):1-5. doi: 10.1177/000313480707300101. — View Citation
Cinat ME, Wallace WC, Nastanski F, West J, Sloan S, Ocariz J, Wilson SE. Improved survival following massive transfusion in patients who have undergone trauma. Arch Surg. 1999 Sep;134(9):964-8; discussion 968-70. doi: 10.1001/archsurg.134.9.964. — View Citation
Como JJ, Dutton RP, Scalea TM, Edelman BB, Hess JR. Blood transfusion rates in the care of acute trauma. Transfusion. 2004 Jun;44(6):809-13. doi: 10.1111/j.1537-2995.2004.03409.x. — View Citation
Consunji R, Elseed A, El-Menyar A, Sathian B, Rizoli S, Al-Thani H, Peralta R. The effect of massive transfusion protocol implementation on the survival of trauma patients: a systematic review and meta-analysis. Blood Transfus. 2020 Nov;18(6):434-445. doi — View Citation
Criddle LM, Eldredge DH, Walker J. Variables predicting trauma patient survival following massive transfusion. J Emerg Nurs. 2005 Jun;31(3):236-42; quiz 320. doi: 10.1016/j.jen.2005.03.004. — View Citation
Dzik WS, Ziman A, Cohn C, Pai M, Lozano M, Kaufman RM, Delaney M, Selleng K, Murphy MF, Hervig T, Yazer M; Biomedical Excellence for Safer Transfusion Collaborative. Survival after ultramassive transfusion: a review of 1360 cases. Transfusion. 2016 Mar;56 — View Citation
Ellingson KD, Sapiano MRP, Haass KA, Savinkina AA, Baker ML, Chung KW, Henry RA, Berger JJ, Kuehnert MJ, Basavaraju SV. Continued decline in blood collection and transfusion in the United States-2015. Transfusion. 2017 Jun;57 Suppl 2(Suppl 2):1588-1598. d — View Citation
Giancarelli A, Birrer KL, Alban RF, Hobbs BP, Liu-DeRyke X. Hypocalcemia in trauma patients receiving massive transfusion. J Surg Res. 2016 May 1;202(1):182-7. doi: 10.1016/j.jss.2015.12.036. Epub 2015 Dec 30. — View Citation
Hakala P, Hiippala S, Syrjala M, Randell T. Massive blood transfusion exceeding 50 units of plasma poor red cells or whole blood: the survival rate and the occurrence of leukopenia and acidosis. Injury. 1999 Nov;30(9):619-22. doi: 10.1016/s0020-1383(99)00 — View Citation
Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg — View Citation
Huber-Wagner S, Qvick M, Mussack T, Euler E, Kay MV, Mutschler W, Kanz KG; Working Group on Polytrauma of German Trauma Society (DGU). Massive blood transfusion and outcome in 1062 polytrauma patients: a prospective study based on the Trauma Registry of t — View Citation
Johnson JL, Moore EE, Kashuk JL, Banerjee A, Cothren CC, Biffl WL, Sauaia A. Effect of blood products transfusion on the development of postinjury multiple organ failure. Arch Surg. 2010 Oct;145(10):973-7. doi: 10.1001/archsurg.2010.216. — View Citation
Kivioja A, Myllynen P, Rokkanen P. Survival after massive transfusions exceeding four blood volumes in patients with blunt injuries. Am Surg. 1991 Jun;57(6):398-401. — View Citation
Malone DL, Dunne J, Tracy JK, Putnam AT, Scalea TM, Napolitano LM. Blood transfusion, independent of shock severity, is associated with worse outcome in trauma. J Trauma. 2003 May;54(5):898-905; discussion 905-7. doi: 10.1097/01.TA.0000060261.10597.5C. — View Citation
McDaniel LM, Etchill EW, Raval JS, Neal MD. State of the art: massive transfusion. Transfus Med. 2014 Jun;24(3):138-44. doi: 10.1111/tme.12125. — View Citation
Mitra B, O'Reilly G, Cameron PA, Zatta A, Gruen RL. Effectiveness of massive transfusion protocols on mortality in trauma: a systematic review and meta-analysis. ANZ J Surg. 2013 Dec;83(12):918-23. doi: 10.1111/ans.12417. Epub 2013 Oct 21. — View Citation
Moore FA, Moore EE, Sauaia A. Blood transfusion. An independent risk factor for postinjury multiple organ failure. Arch Surg. 1997 Jun;132(6):620-4; discussion 624-5. — View Citation
Robinson WP 3rd, Ahn J, Stiffler A, Rutherford EJ, Hurd H, Zarzaur BL, Baker CC, Meyer AA, Rich PB. Blood transfusion is an independent predictor of increased mortality in nonoperatively managed blunt hepatic and splenic injuries. J Trauma. 2005 Mar;58(3) — View Citation
Stanworth SJ, Morris TP, Gaarder C, Goslings JC, Maegele M, Cohen MJ, Konig TC, Davenport RA, Pittet JF, Johansson PI, Allard S, Johnson T, Brohi K. Reappraising the concept of massive transfusion in trauma. Crit Care. 2010;14(6):R239. doi: 10.1186/cc9394 — View Citation
Toner RW, Pizzi L, Leas B, Ballas SK, Quigley A, Goldfarb NI. Costs to hospitals of acquiring and processing blood in the US: a survey of hospital-based blood banks and transfusion services. Appl Health Econ Health Policy. 2011;9(1):29-37. doi: 10.2165/11 — View Citation
Vaslef SN, Knudsen NW, Neligan PJ, Sebastian MW. Massive transfusion exceeding 50 units of blood products in trauma patients. J Trauma. 2002 Aug;53(2):291-5; discussion 295-6. doi: 10.1097/00005373-200208000-00017. — View Citation
Yu AJ, Inaba K, Biswas S, de Leon LA, Wong M, Benjamin E, Lam L, Demetriades D. Supermassive Transfusion: A 15-Year Single Center Experience and Outcomes. Am Surg. 2018 Oct 1;84(10):1617-1621. — View Citation
* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 24-hour mortality | 24-hour mortality (yes/no) | 24 hours | |
Secondary | ICU length of stay | ICU length of stay (days) | through study completion, an average of 1 year | |
Secondary | hospital length of stay | hospital length of stay (days) | through study completion, an average of 1 year | |
Secondary | mechanical ventilator days | mechanical ventilator days | through study completion, an average of 1 year | |
Secondary | complications | complications (yes/no) | through study completion, an average of 1 year | |
Secondary | Multiple organ system failure | Multiple organ system failure (yes/no) | through study completion, an average of 1 year | |
Secondary | In-hospital mortality | In-hospital mortality (yes/no) | through study completion, an average of 1 year | |
Secondary | 30-day mortality | 30-day mortality (yes/no) | 30 days | |
Secondary | discharge disposition | discharge disposition | through study completion, an average of 1 year |
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