Effect of Dabigatran on Coagulation parameters-an ex Vivo... | NCT01112202

Studies
Effect of Dabigatran on Coagulation parameters-an ex Vivo Study

NCT01112202

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Completed

Last Update Posted

Jun 6, 2012Estimated

Enrollment

70Estimated

Phase

Not provided

Conditions

Effect of Dabigatran in Laboratory Coagulation Parameters

Interventions

Not provided

Countries

Germany

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

Apr 2010

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

Apr 2010

Primary Completion Date

Feb 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Apr 27, 2010

First Submission Date that Met QC Criteria

Apr 27, 2010

First Posted Date

Apr 28, 2010Estimated

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

Jun 5, 2012

Last Update Posted Date

Jun 6, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Dabigatran represent a new class of promising anticoagulation agents. As an oral direct thrombin inhibitor it has been effective in preventing venous thromboembolism in patients undergoing elective orthopaedic surgery. This ex vivo study is undertaken to investigate the ex-vivo effects of Pradaxa® on different coagulation parameters.

Detailed Description

This mono-centric, open-label study is undertaken to validate the effects of Dabigatran on coagulation parameters in plasma samples of 70 patients after hip or knee replacement surgery treated with Dabigatran 150-220 mg/d. Plasma samples are obtained by blood collection before, after 2 hours and after 12-14 hours after Dabigatran dosing in steady state (on 3rd - 5th day).

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 y

Exclusion Criteria:

Hemorrhagic disorder
Liver disease
Anemia
Severe renal impairment

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

patients after hip or knee replacement surgery treated with Dabigatran 150-220 mg/d

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johann Wolfgang Goethe University Hospital		Frankfurt		60590	Germany