ong term anticoagulation with low-molecular-weight heparin in a cohort of early neurological rehabilitation patients: does an effective inhibition of activity of factor Xa and factor IIa occur, as well as an increase of tPA and TFPI-levels?

• Conditions: prophylactic LMWH-administration due to temporary or lingering patient's immobility due to their neurological/neurosurgical disease (cohorts 3+4)therapeutic LMWH-administration due to atrial fibrillation, thrombotic or thrombembolic events (cohorts 1+2).administration of oral anticoagulants due to atrial fibrillation, thrombotic or thrombembolic events (cohort 5, control cohort); I74; I48.1; Arterial embolism and thrombosis; Persistent atrial fibrillation

• Registration Number: DRKS00000083
• Lead Sponsor: pharmazentrum frankfurtInstitut für Klinische PharmakologieKlinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2008-10-31
• Study Start: 2009-03-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

patients of early neurological rehabilitation under therapeutic or prophylactic LMWH treatment

patients of early neurological rehabilitation under oral anticoagulant treatment

Exclusion Criteria

necessity of periodical hemodialysis treatment.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
anti-FXa-activity - measured on an ACL6000 coagulation analyzer<br><br>samplings take place on day 7 as well as one month and two months after treatment initiation with LMWH. Anti-FXa-activity is analyzed on these days before LMWH-administration (0h, minimum level) as well as 4h (4h, peak level) and - in case of therapeutic indication/dosage treated patients - 12 h thereafter, before second LMWH-administration on that day . In control cohort patients, (cohort 5, oral anticoagulants), samplings take place at corresponding timepoints (0h & 4h) at 2 different occasions, separated by 4 weeks.

Secondary Outcome Measures

Name	Time	Method
anti-FIIa-activity - measured on an ACL6000 coagulation analyzer.<br><br>plasma levels of D-Dimer and TFPI - measured by ELISA technique. <br><br>endogenous thrombin potential (ETP) - measured on a Fluoroskan Ascent Type 374 microplate fluorometer.<br><br>samplings take place on day 7 as well as one month and two months after treatment initiation with LMWH. Anti-FIIa-activity as well as the further secondary endpoint parameters are analyzed on these days before LMWH-administration (0h, minimum level) as well as 4h (4h, peak level) and - in case of therapeutic indication/dosage treated patients - 12 h thereafter, before second LMWH-administration on that day . In control cohort patients, (cohort 5, oral anticoagulants), samplings take place at corresponding timepoints (0h & 4h) at 2 different occasions, separated by 4 weeks.<br><br>D-Dimer-levels will be analyzed only of 0h-samples.