NCT00168077

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_3

Geographic Reach
8 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

February 11, 2011

Status Verified

February 1, 2011

First QC Date

September 12, 2005

Last Update Submit

February 10, 2011

Conditions

Acquired Coagulation Factor Deficiency

Keywords

Prothrombin Complex ConcentrateAnticoagulant reversal

Outcome Measures

Primary Outcomes (1)

  • Rapid reversal of anticoagulatory effect

Secondary Outcomes (2)

  • Clinical efficacy assessment (hemostatic effect)

  • Increase of coagulation factors

Interventions

Prothrombin Complex ConcentrateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Clinical Trials Registration Coordinator

Feldkirch, 6800, Austria

Location

Clinical Trials Registration Coordinator

Vienna, 1090, Austria

Location

Clinical Trials Registration Coordinator

Halle, 06112, Germany

Location

Clinical Trials Registration Coordinator

Hanover, 30623, Germany

Location

Clinical Trials Registration Coordinator

Leipzig, 04129, Germany

Location

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

Marburg, 35002, Germany

Location

Clinical Trials Registration Coordinator

München, 81377, Germany

Location

Clinical Trials Registration Coordinator

Győr, 9023, Hungary

Location

Clinical Trials Registration Coordinator

Veszprém, 8220, Hungary

Location

Clinical Trials Registration Coordinator

Haifa, 31096, Israel

Location

Clinical Trials Registration Coordinator

Kaunas, 500009, Lithuania

Location

Clinical Trials Registration Coordinator

Vilnius, 08661, Lithuania

Location

Clinical Trials Registration Coordinator

Amsterdam, 1105 AZ, Netherlands

Location

Clinical Trials Registration Coordinator

Warsaw, 02-097, Poland

Location

Clinical Trials Registration Coordinator

Zurich, 8091, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 18208533RESULT

  • 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.

    PMID: 19787352RESULT

MeSH Terms

Conditions

Hemophilia B

Interventions

Factor IX

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Intervention Hierarchy (Ancestors)

Enzyme PrecursorsEnzymes and CoenzymesBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Study Officials

  • Ingrid Pabinger-Fasching, Prof.

    Universitätsklinik für Innere Medizin I der Stadt Wien

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

September 1, 2005

Study Completion

November 1, 2006

Last Updated

February 11, 2011

Record last verified: 2011-02

Locations

AU(2)HU(2)DE(5)IL(1)NL(1)CH(1)LI(2)PL(1)