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

February 14, 2013
April 30, 2013
April 2012
April 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01795781 on ClinicalTrials.gov Archive Site
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Assays for and Reversal of New Anticoagulants
Development of Anticoagulant Assays for New Anticoagulants and Their Reversibility in Vitro

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

  • Atrial Fibrillation
  • Osteoarthritis of the Knee
  • Osteoarthritis of the Hip
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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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01795781
2011/117
No
R.P.Herrmann, Royal Perth Hospital
R.P.Herrmann
Not Provided
Principal Investigator: Ross I Baker, MB, BS Royal Perth Hospital, Wellington St, Perth, Australia
Royal Perth Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP