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CompletedNCT01159210Updated May 5, 2021

Efficacy and Safety of Prothromplex Total (Prothrombin Complex Concentrate) in Oral Anticoagulant Reversal

A Phase 4 interventional study of Prothrombin complex concentrate (coagulation factors IX, II, VII and X in combination) in Prothrombin Complex Factor Deficiency, sponsored by Baxalta now part of Shire. Completed at 6 sites in 2 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2021-05-05.

Sponsored by Baxalta now part of Shire · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
61
Allocation
Non-randomized
Ages
16 Years and older
Sex
All
01

Study summary

The purpose of the study is to assess the efficacy and safety of Prothromplex Total as a treatment for the immediate reversal of oral anticoagulant therapy with vitamin K antagonists in patients with acquired deficiency of prothrombin complex coagulation factors (II, VII, IX, X). Upon enrolment, subjects will receive Prothromplex Total for the treatment of acute bleeding due to oral anticoagulants or for the prevention of excessive bleeding during the interventional procedure (Day 1). Additional doses of Prothromplex Total may be administered at the discretion of the investigator. Efficacy and safety assessments will be performed during a period of 72 (± 4) hours after administration of the last dose of Prothromplex Total or until discharge from hospital, whichever occurs first.

02

Conditions studied

  • Prothrombin Complex Factor Deficiency
03

In context

Lead sponsor

Baxalta now part of Shire is the lead sponsor of 110 studies on the registry; none are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subject is at least 16 years or older at enrolment with acquired deficiency of prothrombin complex coagulation factors (II, VII, IX, X), due to oral anticoagulation with vitamin K antagonists (e.g. coumarin, warfarin), requiring reversal of oral anticoagulation for urgent surgery, or invasive procedure or acute bleeding episode
  • Subject or parent/legally authorised representative has provided written informed consent
  • Subject has INR >= 2,0 at screening
  • Subject is willing and able to comply with the requirements of the protocol

Exclusion criteria

Exclusion Criteria:

  • Subject has laboratory and/or clinical symptoms which are clearly indicative of overt disseminated intravascular coagulation (DIC)
  • Subject has been treated with whole blood, fresh frozen plasma (FFP), or platelets within 6 hours prior to study enrolment
  • Subject has a hypersensitivity to prothrombin complex concentrate (PCC) constituents (including heparin-induced thrombocytopenia)
  • Subject has blood loss of >= 5 units of blood
  • Subject has hereditary thrombophilia or bleeding disorder
  • Subject has a life expectancy of \< 3 months
  • Subject has been on oral anticoagulant treatment for a period of \< 4 weeks for the treatment of a thrombotic event such as deep vein thrombosis or pulmonary embolism
  • Subject has an acute ischemic cardiovascular disorder
  • Subject has or is suspected to have sepsis
  • Subject with acute or chronic liver failure (hepatic cirrhosis Child-PUGH score C)
  • Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrolment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
61 participants (actual)

Interventions

  • BiologicalProthrombin complex concentrate (coagulation factors IX, II, VII and X in combination)

    Intravenous infusion; regimen is guided by the pre-treatment international normalised ratio (INR); dosage and duration of replacement therapy depend on the severity of the disorder, on the location and extent of bleeding and on the patient´s clinical condition.

    Also known as: Prothromplex Total

06

What researchers measure

Primary outcomes

  1. Proportion of subjects who achieve normalisation of International normalised ratio (INR) to <= 1.3 within 30 (±5) minutes post administration of Prothromplex Total

    Time frame: within 35 minutes after administration of study drug

07

Study locations

6 sites
  • Landeskrankenhaus Feldkirch
    Feldkirch, 6807, Austria
  • Universitätsklinik für Innere Medizin I (University Hospital for Internal Medicine I), Allgemeines Krankenhaus der Stadt Wien (General Hospital Vienna)
    Vienna, 1090, Austria
  • Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
    Vienna, 1130, Austria
  • DEOEC, University of Debrecen, Medical and Health Science Centre
    Debrecen, 4032, Hungary
  • Fejer Megyei Szent György Korhaz
    Szekesfehervar, 8000, Hungary
  • Veszprem Megyei Csolnoky Korhaz Nonprofit Zrt., Belgyógyászati Centrum, Haematológiai Részleg
    Veszprem, 8200, Hungary
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01159210
Lead sponsor
Baxalta now part of Shire
Responsible party
Sponsor
First posted
Jul 9, 2010
Start date
Jul 9, 2010
Primary completion
Apr 7, 2012
Completion
Apr 7, 2012
Last update
May 5, 2021

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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