Anticoagulant Prophylaxis/Therapy Clinical Trial
Official title:
Determination of Residual Anticoagulatory Effects of Prophylactic or Therapeutic Treatment With Fondaparinux
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.
| Status | Recruiting |
| Enrollment | 110 |
| Est. completion date | October 2010 |
| Est. primary completion date | September 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Fondaparinux therapy for at least 3 days Exclusion Criteria: - Age < 18 years - Hemodialysis |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | J.W. Goethe University Hospital Frankfurt/M. | Frankfurt am Main | Hessen |
| Lead Sponsor | Collaborator |
|---|---|
| Johann Wolfgang Goethe University Hospitals |
Germany,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | antiXa-levels (peak- and through-levels) | between day 3 and day 14 after start of therapy | Yes | |
| Secondary | thromboembolic or bleeding episodes, HIT | day 14 after start of therapy | Yes |