Recruiting

PCC & rFVIIa

Sponsor:

Zeliha Alicikus

Code:

NCT07290634

Conditions

Thromboembolus

Massive Blood Transfusion; Thrombocytopenia

Trauma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Number of Participants with massive blood transfusion

Study Details

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

Massive Blood Transfusion; Thrombocytopenia

Trauma

Study ID

NCT07290634

Start date

Apr 30, 2026

Status verified date

Apr, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

May 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

4 participants

Anticipated

Interventions and Outcome Measures

Arms

PCC group

patients receiving PCC during resuscitation

rFVIIa group

patients receiving rFVIIa

Combination group

patients receiving both PCC and rFVIIa

Control group

patients who received standard resuscitation without PCC or rFVIIa

Interventions

Number of Participants with massive blood transfusion

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

Primary outcome measure

  • thromboembolic events [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Locations

UF Health Jacksonville (Shands Hospital)

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

UF Health Jacksonville (Shands Hospital)

Recruiting

Jacksonville, Florida, United States, 32218

Contacts

More Information

Sponsor

Zeliha Alicikus

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Zeliha Alicikus on 2026-04-14.