Comparative Outcomes of PCC and Recombinant Activated Factor VIIa in Trauma-Associated Massive Transfusion

NCT07290634 | Recruiting

• 1 other identifier: AYTEN-2 FACTOR
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to compare the incidence of thromboembolic complications among trauma patients receiving PCC, rFVIIa, both agents, or neither during massive transfusion. Secondary objectives include comparing mortality, transfusion requirements, intensive care unit (ICU) and hospital length of stay, ventilator-free days, and the incidence of transfusion-associated adverse events such as transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO). Subgroup analyses will evaluate outcomes in patients with and without laboratory-confirmed TIC (INR \>1.2).

Conditions

Thromboembolus; Trauma; Massive Blood Transfusion; Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• thromboembolic events

  Number of Participants with venous thrombosis, pulmonary embolism, ischemic stroke, mesenteric ischemia

  28 days

Secondary Outcomes (1)

• ICU and hospital stay

  28 days

Study Arms (4)

PCC group

patients receiving PCC during resuscitation

Procedure: Number of Participants with massive blood transfusion

rFVIIa group

patients receiving rFVIIa

Procedure: Number of Participants with massive blood transfusion

Combination group

patients receiving both PCC and rFVIIa

Procedure: Number of Participants with massive blood transfusion

Control group

patients who received standard resuscitation without PCC or rFVIIa

Procedure: Number of Participants with massive blood transfusion

Interventions

Number of Participants with massive blood transfusion PROCEDURE

evaluate the impact of Prothrombin Complex, recombinant activated factor VII, and their combination on outcomes in adult trauma patients undergoing massive transfusion.

Combination group; Control group; PCC group; rFVIIa group

Eligibility Criteria

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

Study Population

This will be a retrospective cohort study conducted between 1 January 2023 to 1 October 2025 at University of Florida Jacksonville trauma center. The study will evaluate the impact of Prothrombin Complex, recombinant activated factor VII, and their combination on outcomes in adult trauma patients undergoing massive transfusion.

You may qualify if:

• Adults ≥18 years
• Trauma patients directly admitted from the scene with highest-level trauma activation: Injury -Severity Score (ISS) \>15.
• Requirement for massive transfusion, defined as ≥3 units packed red blood cells (PRBC) within the first hour or ≥10 PRBC within the first 24 hours

You may not qualify if:

• Traumatic cardiac injury
• Death anticipated within the first hour of admission: ISS score \>49
• Pre-injury anticoagulant therapy
• Known pregnancy
• Pre-injury terminal illness

Sponsors & Collaborators

• Zeliha Alicikus: lead

Study Sites (2)

UF Health Jacksonville (Shands Hospital)

Jacksonville, Florida, 32209, United States

RECRUITING

UF Health Jacksonville (Shands Hospital)

Jacksonville, Florida, 32218, United States

RECRUITING

MeSH Terms

Conditions

Thromboembolism; Thrombocytopenia; Wounds and Injuries

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• AYTEN SARAÇOĞLU, Prof,MD

  Florida University Jacksonville

  STUDY DIRECTOR

Central Study Contacts

Ayten SARAÇOĞLU, Prof,MD

CONTACT

+1 (904) 524-4331; anesthesiayten@gmail.com

Tolga SARAÇOĞLU, Prof,MD

CONTACT

+1 (904) 524-5932; kemaltolgasaracoglu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Anesthesiology and Reanimation department,Assoc Prof

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 18, 2025
• Study Start: April 30, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)