NCT01101256

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

April 13, 2010

Status Verified

April 1, 2010

Enrollment Period

5 months

First QC Date

April 7, 2010

Last Update Submit

April 12, 2010

Conditions

Anticoagulant Prophylaxis/Therapy

Outcome Measures

Primary Outcomes (1)

  • antiXa-levels (peak- and through-levels)

    between day 3 and day 14 after start of therapy

Secondary Outcomes (1)

  • thromboembolic or bleeding episodes, HIT

    day 14 after start of therapy

Study Arms (2)

Fondaparinux Prophylaxis group

Fondaparinux Therapy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with s.c. anticoagulant therapy (fondaparinux)

You may qualify if:

  • Fondaparinux therapy for at least 3 days

You may not qualify if:

  • Age \< 18 years
  • Hemodialysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

J.W. Goethe University Hospital Frankfurt/M.

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 14572200BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Citrated blood

Study Officials

  • Marc Schindewolf, MD

    J.W. Goethe University Hospital Frankfurt/M.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Schindewolf, MD

CONTACT

+49 (0)69 6301marcschindewolf@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2010

First Posted

April 9, 2010

Study Start

April 1, 2010

Primary Completion

September 1, 2010

Study Completion

October 1, 2010

Last Updated

April 13, 2010

Record last verified: 2010-04

Locations

DE(1)