Transfusion Using Stored Whole Blood

NCT02926274 | Completed

• 1 other identifier: NTI-JWMRP-201501
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

Massive hemorrhage is a major cause of potentially preventable death following trauma. A common consequence of hemorrhagic shock is uncontrollable bleeding from coagulopathy, leading to death from exsanguination. Even when bleeding is controlled, patients are at increased risk of complications and mortality. Reconstituted whole blood, or component therapy with packed red blood cells (PRBCs), plasma, and platelets was introduced by the military in recent conflicts in Iraq and Afghanistan with remarkable results and has been adopted by most civilian trauma centers. Despite improving coagulopathy, it is apparent that transfusion of blood components is not equivalent to whole blood transfusion. Transfusion of high plasma volumes may be associated with increased risk of allergic reaction, transfusion associated acute lung injury (TRALI), hypervolemic cardiac failure, and acute respiratory distress syndrome (ARDS). Military services have recently reintroduced fresh whole blood (WB) for standard resuscitation of massive hemorrhage, have found that WB offers a survival advantage over component therapy, and that risks of transfusion reactions are similar for WB and PRBCs. On the civilian side, whole blood is an FDA-licensed product that has been in use in pediatric open heart surgery and autologous blood donation but is no longer commonly available for other indications. However, the military results are renewing interest in whole blood for trauma resuscitation. The use of low-antibody titer whole blood leukoreduced with a platelet-sparing filter was recently approved by the University of California Los Angeles Blood and Blood Derivatives Committee and two other trauma centers for male trauma patients. This study will test the feasibility of providing stored WB for resuscitation of patients in hemorrhagic shock and determine the effects of WB on clinical outcomes as well as the effects on coagulation, fibrinolysis, and inflammation, compared to standard blood component therapy.

Conditions

Trauma; Hemorrhage; Coagulopathy

Keywords

whole blood; trauma; transfusion; coagulopathy

Outcome Measures

Primary Outcomes (1)

• Volume of blood products transfused during resuscitation

  Volume of blood products transfused (whole blood, packed red blood cells, platelets, and plasma) within the first 24 hours of admission.

  From admission to 24 hours after admission

Secondary Outcomes (20)

• mortality

  Mortality at 30 days after injury

• platelet mapping by thromboelastography

  within one day of injury, after 6 units of whole blood or packed red blood cell transfusion, or after hemostasis is achieved if less than 6 units are required

• Thromboelastography reaction time

  within one day of injury, after 6 units of whole blood or packed red blood cell transfusion, or after hemostasis is achieved if less than 6 units are required

• Thromboelastography K value

  within one day of injury, after 6 units of whole blood or packed red blood cell transfusion, or after hemostasis is achieved if less than 6 units are required

• Thromboelastography maximum amplitude (MA)

  within one day of injury, after 6 units of whole blood or packed red blood cell transfusion, or after hemostasis is achieved if less than 6 units are required

Study Arms (2)

Whole Blood

Adult male trauma patients presenting with systolic blood pressure \<100 will receive up to 6 units of whole blood when available.

Component therapy

Adult female patients presenting with systolic blood pressure \<100, as well as adult male patients with systolic blood pressure \<100 during periods when whole blood is not available, will receive component therapy (1:1:1 packed red blood cells: plasma:platelets) for transfusion.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All trauma patients presenting to Ronald Reagan UCLA Medical Center with systolic blood pressure \<100 suspected due to hemorrhage are eligible. Adult males will receive whole blood when available. Adult female patients will receive component therapy.

You may qualify if:

• All adult trauma patients presenting to Ronald Reagan University of California Los Angeles (UCLA) Medical Center with systolic blood pressure \<100 suspected due to hemorrhage are eligible. Adult males will receive whole blood when available. Adult female patients will receive component therapy.

You may not qualify if:

• Burn patients, patients with medical bracelets or other directives refusing blood transfusion if known during emergent resuscitation for traumatic injury, pediatric patients

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Siletz AE, Blair KJ, Cooper RJ, Nguyen NC, Lewis SJ, Fang A, Ward DC, Jackson NJ, Rodriguez T, Grotts J, Hwang J, Ziman A, Cryer HM. A pilot study of stored low titer group O whole blood + component therapy versus component therapy only for civilian trauma patients. J Trauma Acute Care Surg. 2021 Oct 1;91(4):655-662. doi: 10.1097/TA.0000000000003334.

  PMID: 34225348 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Wounds and Injuries; Hemorrhage; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: October 6, 2016
• Study Start: October 18, 2017
• Primary Completion: August 24, 2019
• Study Completion: August 24, 2019
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)