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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Zeliha Alicikus
Study ID
NCT07290634
Status
Recruiting
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Conditions

  • Massive Blood Transfusion; Thrombocytopenia
  • Thromboembolus
  • Trauma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
May 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
4 participants (estimated)

Arms

  • Arm: PCC group
    patients receiving PCC during resuscitation
  • Arm: rFVIIa group
    patients receiving rFVIIa
  • Arm: Combination group
    patients receiving both PCC and rFVIIa
  • Arm: Control group
    patients who received standard resuscitation without PCC or rFVIIa

Primary Outcome Measure

thromboembolic events [ Time Frame: 28 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UF Health Jacksonville (Shands Hospital)JacksonvilleFlorida32209
TOLGA Saraçoğlu, prof,md
[email protected]
904-524-5932
AYTEN Saraçoğlu, PROF,MD
[email protected]
+1 (904) 524-4331
UF Health Jacksonville (Shands Hospital)JacksonvilleFlorida32218
AYTEN SARAÇOĞLU, PROF,MD
[email protected]
904-524-4331
TOLGA SARAÇOĞLU, PROF,MD
[email protected]
+1 (904) 524-5932

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By research site
UF Health Jacksonville (Shands Hospital)· Jacksonville, FL

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