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Prothrombin Complex Concentrate for Anticoagulant Reversal

NCT ID: NCT00168077

Last Updated: 2011-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-11-30

Brief Summary

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Patients on oral anticoagulants need rapid reversal of the anticoagulant effect in case of acute bleeding or emergency surgery. Prothrombin Complex Concentrates are known to provide a fast reversal of the anticoagulant effect, with several advantages over alternatives like vitamin K or FFP.The planned clinical Phase III study is designed to provide clinically relevant data on efficacy and safety.

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Detailed Description

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Conditions

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Acquired Coagulation Factor Deficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Prothrombin Complex Concentrate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects on oral anticoagulation requiring rapid reversal due to acute bleeding or emergency surgery
* INR \> 2 at baseline

Exclusion Criteria

* Acute thromboembolic event
* Treatment with any other investigational drug in the last 30 days before study entry
* Less than 2 weeks of stable oral anticoagulation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CSL Behring

INDUSTRY

Sponsor Role lead

Responsible Party

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CSL Behring

Principal Investigators

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Ingrid Pabinger-Fasching, Prof.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik für Innere Medizin I der Stadt Wien

Locations

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Clinical Trials Registration Coordinator

Feldkirch, , Austria

Site Status

Clinical Trials Registration Coordinator

Vienna, , Austria

Site Status

Clinical Trials Registration Coordinator

Halle, , Germany

Site Status

Clinical Trials Registration Coordinator

Hanover, , Germany

Site Status

Clinical Trials Registration Coordinator

Leipzig, , Germany

Site Status

For information on sites in Europe, please contact our clinical research team in

Marburg, , Germany

Site Status

Clinical Trials Registration Coordinator

München, , Germany

Site Status

Clinical Trials Registration Coordinator

Győr, , Hungary

Site Status

Clinical Trials Registration Coordinator

Veszprém, , Hungary

Site Status

Clinical Trials Registration Coordinator

Haifa, , Israel

Site Status

Clinical Trials Registration Coordinator

Kaunas, , Lithuania

Site Status

Clinical Trials Registration Coordinator

Vilnius, , Lithuania

Site Status

Clinical Trials Registration Coordinator

Amsterdam, , Netherlands

Site Status

Clinical Trials Registration Coordinator

Warsaw, , Poland

Site Status

Clinical Trials Registration Coordinator

Zurich, , Switzerland

Site Status

Countries

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Austria Germany Hungary Israel Lithuania Netherlands Poland Switzerland

References

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Pabinger I, Brenner B, Kalina U, Knaub S, Nagy A, Ostermann H; Beriplex P/N Anticoagulation Reversal Study Group. Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial. J Thromb Haemost. 2008 Apr;6(4):622-31. doi: 10.1111/j.1538-7836.2008.02904.x. Epub 2008 Jan 15.

Reference Type RESULT
PMID: 18208533 (View on PubMed)

Pabinger I, Tiede A, Kalina U, Knaub S, Germann R, Ostermann H; Beriplex P/N Anticoagulation Reversal Study Group. Impact of infusion speed on the safety and effectiveness of prothrombin complex concentrate: a prospective clinical trial of emergency anticoagulation reversal. Ann Hematol. 2010 Mar;89(3):309-16. doi: 10.1007/s00277-009-0830-7. Epub 2009 Sep 29.

Reference Type RESULT
PMID: 19787352 (View on PubMed)

Other Identifiers

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BE1116_3001

Identifier Type: -

Identifier Source: org_study_id

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