Prothrombin Complex Concentrate for Anticoagulant Reversal | NCT00168077

Studies
Prothrombin Complex Concentrate for Anticoagulant Reversal

NCT00168077

Sponsor

CSL Behring

Status

Completed

Last Update Posted

Feb 11, 2011Estimated

Enrollment

Phase

Phase 3

Conditions

Acquired Coagulation Factor Deficiency

Interventions

Prothrombin Complex Concentrate

Countries

Austria
Germany
Hungary
Israel
Lithuania
Netherlands
Poland
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Nov 2006Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2011

Last Update Posted Date

Feb 11, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Prothrombin Complex Concentrate	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rapid reversal of anticoagulatory effect

Secondary Outcomes

Measure	Description	Time Frame
Clinical efficacy assessment (hemostatic effect)
Increase of coagulation factors

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

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

Key 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ingrid Pabinger-Fasching, Prof.	Universitätsklinik für Innere Medizin I der Stadt Wien	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Trials Registration Coordinator		Feldkirch		6800	Austria
Clinical Trials Registration Coordinator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18208533	Result	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.
19787352

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

ID	Term
D004792	Enzyme Precursors
D045762	Enzymes and Coenzymes
D001779	Blood Coagulation Factors
D001798	Blood Proteins