Assays for and Reversal of New Anticoagulants

New anticoagulants are being introduced to replace warfarin. These drugs do not require monitoring and are safer. There is currently no recommended way to reverse these drugs rapidly in the event of undue bleeding or need for emergency surgery. This is a lab study to look at ways to reverse the drugs rapidly

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Arthritis Cardiovascular Diseases Heart Diseases Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis of the Hip Osteoarthritis of the Knee Osteoarthritis, Hip Osteoarthritis, Knee Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Receiving dabigatran for atrial fibrillation
Or,for osteoarthritis of the hip or knee receiving rivaroxaban to prevent thromboembolic disease after total hip or knee replacement respectively

Exclusion criteria

Failure to sign informed consent

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

R.P.Herrmann

Other

Registry information

Official study title

Development of Anticoagulant Assays for New Anticoagulants and Their Reversibility in Vitro

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Feb 21, 2013
Registry last updated: May 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed