Comparing Treatments for Bleeding in Trauma Patients

This study is looking at how well two treatments, Prothrombin Complex Concentrate (PCC) and recombinant activated factor VIIa (rFVIIa), work in adult trauma patients who need a lot of blood transfusions. Researchers want to see if these treatments, used alone or together, can reduce serious blood clots (thromboembolic events). They will also compare how these treatments affect survival, how much blood is needed, and how long patients stay in the hospital or ICU. You might be able to join if you are an adult (18 or older) with severe trauma who needs a massive blood transfusion. The study will look at these outcomes 28 days after treatment.

Study design
This is an observational study, meaning researchers will watch and collect information from a small group of 4 participants. It is not specified if participants will be assigned to different treatment groups.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will check for blood clots (thromboembolic events) 28 days after treatment.

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NCT07290634

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

Recruiting
Not specifiedAges 18+Observational
Zeliha Alicikus
~4 participants
Updated 2026-04-14 on ClinicalTrials.gov
What's tested:Number of Participants with massive blood transfusion

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
thromboembolic events
Measured over 28 days
Thromboembolus
Massive Blood Transfusion; Thrombocytopenia
Trauma
2 sites across 1 states
Florida2
  • AYTEN SARAÇOĞLU, Prof,MD · STUDY_DIRECTOR · Florida University Jacksonville

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Eligibility criteria

Inclusion

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

Traumatic cardiac injury
Death anticipated within the first hour of admission: ISS score \>49
Pre-injury anticoagulant therapy
Known pregnancy
Pre-injury terminal illness
  • thromboembolic events28 days

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