Determination of Residual Anticoagulatory Effects of Fond... | NCT01101256

Studies
Determination of Residual Anticoagulatory Effects of Fondaparinux

NCT01101256

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Unknown status

Last Update Posted

Apr 13, 2010Estimated

Enrollment

110Estimated

Phase

Not provided

Conditions

Anticoagulant Prophylaxis/Therapy

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

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Sep 2010Estimated

Completion Date

Oct 2010Estimated

First Submitted Date

Apr 7, 2010

First Submission Date that Met QC Criteria

Apr 8, 2010

First Posted Date

Apr 9, 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

Apr 12, 2010

Last Update Posted Date

Apr 13, 2010Estimated

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

The purpose of this study is to determine residual anticoagulatory effects of a prophylactic or therapeutic fondaparinux treatment i.e. prior to surgery/intervention, after pause of therapy etc.

Detailed Description

Not provided

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

Retention

Enrollment

110Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
antiXa-levels (peak- and through-levels)		between day 3 and day 14 after start of therapy

Secondary Outcomes

Measure	Description	Time Frame
thromboembolic or bleeding episodes, HIT		day 14 after start of therapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fondaparinux therapy for at least 3 days

Exclusion Criteria:

Age < 18 years
Hemodialysis

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 with s.c. anticoagulant therapy (fondaparinux)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marc Schindewolf, MD	Contact	+49 (0)69 6301	5096	marcschindewolf@yahoo.com

Overall Officials

Name	Affiliation	Role
Marc Schindewolf, MD	J.W. Goethe University Hospital Frankfurt/M.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
J.W. Goethe University Hospital Frankfurt/M.	Recruiting	Frankfurt am Main	Hesse	60590	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14572200	Background	Paolucci F, Frasa H, Van Aarle F, Capdevla A, Clavies MC, van Dinther T, Donat F, Hendriks Y, van den Heuvel M, Nadal T, Lagrange F, Necciari J, Perez Y. Two sensitive and rapid chromogenic assays of fondaparinux sodium (Arixtra) in human plasma and other biological matrices. Clin Lab. 2003;49(9-10):451-60.

Label	Type	Description	Intervention Names
Fondaparinux Prophylaxis group
Fondaparinux Therapy group