Assays for and Reversal of New Anticoagulants
|ClinicalTrials.gov Identifier: NCT01795781|
Recruitment Status : Completed
First Posted : February 21, 2013
Last Update Posted : May 3, 2013
|Condition or disease|
|Atrial Fibrillation Osteoarthritis of the Knee Osteoarthritis of the Hip|
We are developing in vitro assays of measurement of the effect of these drugs on the relevant coagulation pathways in plasma; such assays are not widely established. This will then allow us to test potential reversing agents such as activated Factor VII (Novo-Seven®), or Factor VIII inhibitor bypassing agent (FEIBA) for their ability to reverse these anti-coagulants invitro. The aims of this reversal research strategy is to provide a means whereby patients who present with serious bleeding or who need rapid reversal for surgery, for example, can be offered such treatment to allow rapid normalisation of their coagulation system.
As part of this developmental programme, we wish to obtain samples from patients receiving Rivaroxaban or Dabigatran for therapeutic reasons, to test the effect of the respective drug on the relevant coagulation factors and to test in vitro reversibility.
The only requirement for the patient is to have an extra 20ml of blood taken at a time when the patient is having other blood tests. There are no risks or experimental procedures planned to be carried out on patients.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Development of Anticoagulant Assays for New Anticoagulants and Their Reversibility in Vitro|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Patients receiving a new anticoagulant
Patients are receiving dabigatran for atrial fibrillation or rivaroxaban for osteoarthritis of hip or knee undergoing total hip or knee replacement respectively
- Ability to reverse anticoagulant effect in vitro of dabigatran or rivarovaban [ Time Frame: Two hours after ingestion of anticoagulant dose ]The ability of nonspecific coagulation factors to reverse anticoagulant effect in vitro as measured by dilute thrombin time, Calibrated automated thrombinoscope, thromboelastogram and Rotem
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795781
|Australia, Western Australia|
|Royal Perth Hospital|
|Perth, Western Australia, Australia, 6000|
|Principal Investigator:||Ross I Baker, MB, BS||Royal Perth Hospital, Wellington St, Perth, Australia|