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
Conditions
Interventions
Group 1: Blood withdrawals for determination of coagulation parameters on an observational cohort of early neurological rehabilitation patients under therapeutic tinzaparin treatment (90 IE anti-Xa/kg
Sponsors
pharmazentrum frankfurt
Institut für Klinische Pharmakologie
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: patients of early neurological rehabilitation under therapeutic or prophylactic LMWH treatment patients of early neurological rehabilitation under oral anticoagulant treatment
Exclusion criteria
Exclusion criteria: necessity of periodical hemodialysis treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| anti-FXa-activity - measured on an ACL6000 coagulation analyzer 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
| Measure | Time frame |
|---|---|
| anti-FIIa-activity - measured on an ACL6000 coagulation analyzer. plasma levels of D-Dimer and TFPI - measured by ELISA technique. endogenous thrombin potential (ETP) - measured on a Fluoroskan Ascent Type 374 microplate fluorometer. 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. D-Dimer-levels will be analyzed only of "0h"-samples. | — |
Countries
Germany
Contacts
Public ContactKarina Kuczka
pharmazentrum frankfurt Institut für Klinische Pharmakologie Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main
Outcome results
None listed