Assays for and Reversal of New Anticoagulants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
R.P.Herrmann, Royal Perth Hospital
ClinicalTrials.gov Identifier:
NCT01795781
First received: February 14, 2013
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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
Atrial Fibrillation
Osteoarthritis of the Knee
Osteoarthritis of the Hip

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of Anticoagulant Assays for New Anticoagulants and Their Reversibility in Vitro

Resource links provided by NLM:


Further study details as provided by Royal Perth Hospital:

Primary Outcome Measures:
  • Ability to reverse anticoagulant effect in vitro of dabigatran or rivarovaban [ Time Frame: Two hours after ingestion of anticoagulant dose ] [ Designated as safety issue: Yes ]
    The ability of nonspecific coagulation factors to reverse anticoagulant effect in vitro as measured by dilute thrombin time, Calibrated automated thrombinoscope, thromboelastogram and Rotem


Enrollment: 30
Study Start Date: April 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01795781

Locations
Australia, Western Australia
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
R.P.Herrmann
Investigators
Principal Investigator: Ross I Baker, MB, BS Royal Perth Hospital, Wellington St, Perth, Australia
  More Information

No publications provided

Responsible Party: R.P.Herrmann, Director, Cell and Tissue Therapies, Western Australia, Royal Perth Hospital
ClinicalTrials.gov Identifier: NCT01795781     History of Changes
Other Study ID Numbers: 2011/117
Study First Received: February 14, 2013
Last Updated: April 30, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Royal Perth Hospital:
Anticoagulant measurement
Anticoagulant reversal
Dabigatran
Rivaroxaban

Additional relevant MeSH terms:
Atrial Fibrillation
Osteoarthritis
Osteoarthritis, Hip
Osteoarthritis, Knee
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014