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Trial record 10 of 10 for:    "Collagen Disease" | "Rivaroxaban"

Assays for and Reversal of New Anticoagulants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01795781
Recruitment Status : Completed
First Posted : February 21, 2013
Last Update Posted : May 3, 2013
Information provided by (Responsible Party):
R.P.Herrmann, Royal Perth Hospital

Brief Summary:
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

Condition or disease
Atrial Fibrillation Osteoarthritis of the Knee Osteoarthritis of the Hip

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with atrial fibrillation receiving dabigatran for thrombosis prevention or patients with osteoarthritis of the hip or knee receiving rivaroxaban after total hip or knee replacement respectively for thrombosis prevention

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01795781

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Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
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Principal Investigator: Ross I Baker, MB, BS Royal Perth Hospital, Wellington St, Perth, Australia

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Responsible Party: R.P.Herrmann, Director, Cell and Tissue Therapies, Western Australia, Royal Perth Hospital Identifier: NCT01795781     History of Changes
Other Study ID Numbers: 2011/117
First Posted: February 21, 2013    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: April 2013
Keywords provided by R.P.Herrmann, Royal Perth Hospital:
Anticoagulant measurement
Anticoagulant reversal
Additional relevant MeSH terms:
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Rheumatic Diseases
Osteoarthritis, Knee
Osteoarthritis, Hip
Atrial Fibrillation
Joint Diseases
Musculoskeletal Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes