deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT00243243

Effect of rFVIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn

Effect of Recombinant Coagulation Factor VIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn Excision and Grafting

Sponsor: United States Army Institute of Surgical Research

Conditions Burns
Interventions Placebo Recombinant Factor VIIa
Updated 9 times since 2017 Last updated: Apr 26, 2016 Started: Jan 31, 2006 Primary completion: Jun 30, 2011 Completion: Jul 31, 2011
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Burns and is currently completed. United States Army Institute of Surgical Research leads this study, which shows 9 recorded versions since 2006 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

To identify the clinical use for Factor VIIa in the operating room to reduce blood loss and blood transfusion , determine the Recombinant Factor VIIa (rFVIIa) pharmacokinetics in burned patients, determine if fFVIIa should be used to reduce peri-operative blood loss in patients undergoing excision greater than or equal to 20 percent of the total body surface area, determine the efficacy of the drug in burned patients undergoing excision of burn wounds.

To identify the clinical use for Factor VIIa in the operating room to reduce blood loss and blood transfusion , determine the Recombinant Factor VIIa (rFVIIa) pharmacokinetics in burned patients, determine if fFVIIa should be used to reduce peri-operative blood loss in patients undergoing excision greater than or equal to 20 percent of the total body surface area, determine the efficacy of the drug in burned patients undergoing excision of burn wounds.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

9 versions recorded

  1. Jan 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Present [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE3

▶ Show 4 earlier versions

  1. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE3

  2. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE3

  3. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  4. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE3

    First recorded

Jan 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • United States Army Institute of Surgical Research
Data source: United States Army Institute of Surgical Research

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations