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CLINICAL_TRIALS ClinicalTrials.gov record update

A Phase III, Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of OCTAPLEX, a Four-factor Prothrombin Complex Concentrate (4F-PCC), Compared to the 4F-PCC Beriplex® P/N (Kcentra), for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.

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Record identity and dates

Source
ClinicalTrials.gov
Source record ID
NCT02740335
Title field or adapter rule
protocolSection.identificationModule.officialTitle
Ingested At
2026-04-28T10:39:17.266944+00:00
Published At
2023-03-08T00:00:00+00:00
Record Updated At
2023-03-08
Results Posted At
2023-03-08
Timestamp Basis
source retrieval time was not retained by the feed adapter
Date limitation
source retrieval time was not retained by the feed adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions
["Significant Bleeding Risk"]
protocolSection.statusModule.lastUpdatePostDateStruct.date
"2023-03-08"
protocolSection.identificationModule.nctId
"NCT02740335"
protocolSection.identificationModule.officialTitle
"A Phase III, Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of OCTAPLEX, a Four-factor Prothrombin Complex Concentrate (4F-PCC), Compared to the 4F-PCC Beriplex\u00ae P/N (Kcentra), for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk."
protocolSection.statusModule.overallStatus
"COMPLETED"
protocolSection.designModule.phases
["PHASE3"]
protocolSection.statusModule.resultsFirstPostDateStruct.date
"2023-03-08"

Study condition terms

  • Significant Bleeding Risk (protocolSection.conditionsModule.conditions)

Intervention details are not present in the imported fields for this record. No drug-condition relationship is inferred from co-listing.

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