Drug Induced Dyskinesia Clinical Trials

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Comparative Outcomes of Prothrombin Complex Concentrate and Recombinant Activated Factor VIIa in Trauma-Associated Massive Transfusion: A Retrospective Cohort Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
UF Health Jacksonville (Shands Hospital)
RECRUITING
Jacksonville
UF Health Jacksonville (Shands Hospital)
RECRUITING
Jacksonville
Contact Information
Primary
Ayten SARAÇOĞLU, Prof,MD
anesthesiayten@gmail.com
+1 (904) 524-4331
Backup
Tolga SARAÇOĞLU, Prof,MD
kemaltolgasaracoglu@gmail.com
+1 (904) 524-5932
Time Frame
Start Date: 2026-04-30
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 4
Treatments
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
Sponsors
Leads: Zeliha Alicikus

This content was sourced from clinicaltrials.gov