UltraMTP in Adult Trauma Patients Undergoing Surgery Within 24 Hours: Effects on Mortality and Clinical Outcomes

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04866953
• Other study ID #: APP-21-02050
• Status: Completed
• Start date: August 15, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

Rationale: 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.

Intervention: Blood transfusions administered to adult trauma patients undergoing surgery within 24 hours of admission.

Objectives/Purpose: The main objective of this study is to examine the outcomes associated with large volume transfusions at U.S. level I trauma centers in adult trauma patients undergoing surgery within 24 hours of admission. The investigators aim to determine the mortality rate associated with ultraMTP (defined as >/= 30 units pRBC within 24 hours), and the effects of ultraMTP on secondary outcomes. The investigators would also like to compare outcomes among patients who receive various amounts of pRBC units within 24 hours. The information learned through this study will aid in determining whether there is a threshold transfusion amount, after which outcomes significantly worsen, and resuscitation efforts are futile and should cease, in order to save hospital resources, time, and costs.

Study Population/Sample Characteristics: Adult trauma patients requiring surgery within 24 hours of admission who receive blood products.

Study Methodology: This is a multicenter, retrospective observational study.

Study Endpoints/Outcomes:

• Primary outcome: 24-hour mortality (from the time of admission until 24 hours)

• Secondary outcomes: 1. ICU length of stay (LOS); 2. hospital LOS; 3. MV days; 4. Complications; 5. Multiple organ system failure; 6. in hospital mortality; 7. 30-day mortality; 8. discharge disposition.

Statistics/Analysis Plans:

The investigators will construct a logistic regression prediction model to 1) find the cut point classifications for pRBC units that optimize model prediction and 2) find additional variables that improve the predictive ability of our model. Previous studies on pRBC units and mortality have used different category cut points for pRBC units. The investigators will examine the functional form of pRBC units in its relationship with mortality to determine if there is a "plateau" effect of increasing pRBC units on mortality. The investigators will use this information to guide the classification of pRBC unit categories, comparing AIC values from several models with differing pRBC category classification cut off points to determine which of these are most highly associated with mortality. Using these categories, the investigators will then construct the prediction model, using the variables defined in Section 12. Interactions between these candidate predictors variables and pRBC units will additionally be considered. Model validation will be performed using k-folds cross-validation. Model performance will be evaluated by examining discriminative ability (area under ROC curve), calibration metrics, and optimism.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Blood Transfusion Complication
• Death
• Transfusion Reaction
• Trauma
• Wounds and Injuries

Intervention

Other:
• Blood transfusion
Number of units of blood received within 24 hours of admission

Locations

Country	Name	City	State
United States	Keck School of Medicine of the University of Southern California	Los Angeles	California

Sponsors (9)

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

Country where clinical trial is conducted

United States, 

References & Publications (22)

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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

Outcome

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