Completed PHASE3 INTERVENTIONAL 2-arm NCT00618098

Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures

A Randomized, Open-label, Efficacy and Safety Study of Octaplex and Fresh Frozen Plasma (FFP) in Patients Under Vitamin K Antagonist Therapy With the Need for Urgent Surgery or Invasive Procedures

Sponsor: Octapharma

Conditions Reversal of Anticoagulant Treatment

Interventions Fresh frozen plasma Octaplex (human prothrombin complex concentrate)

Updated 8 times since 2017 Last updated: Jan 5, 2023 Started: May 31, 2008 Primary completion: Mar 31, 2012 Completion: Aug 31, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00618098, this PHASE3 trial focuses on Reversal of Anticoagulant Treatment and remains completed. Sponsored by Octapharma, it has been updated 8 times since 2008, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

8 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Feb 2023 — Jul 2024 [monthly]

Completed PHASE3
Apr 2022 — Feb 2023 [monthly]

Completed PHASE3
Jan 2021 — Apr 2022 [monthly]

Completed PHASE3

▶ Show 3 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

May 2008

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Octapharma

Data source: Octapharma

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

Study Locations

• Philadelphia, United States