NCT01795781

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 21, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

May 3, 2013

Status Verified

April 1, 2013

Enrollment Period

1 year

First QC Date

February 14, 2013

Last Update Submit

April 30, 2013

Conditions

Atrial FibrillationOsteoarthritis of the KneeOsteoarthritis of the Hip

Keywords

Anticoagulant measurementAnticoagulant reversalDabigatranRivaroxaban

Outcome Measures

Primary Outcomes (1)

  • Ability to reverse anticoagulant effect in vitro of dabigatran or rivarovaban

    The ability of nonspecific coagulation factors to reverse anticoagulant effect in vitro as measured by dilute thrombin time, Calibrated automated thrombinoscope, thromboelastogram and Rotem

    Two hours after ingestion of anticoagulant dose

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Failure to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

MeSH Terms

Conditions

Atrial FibrillationOsteoarthritis, KneeOsteoarthritis, Hip

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Ross I Baker, MB, BS

    Royal Perth Hospital, Wellington St, Perth, Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Cell and Tissue Therapies, Western Australia

Study Record Dates

First Submitted

February 14, 2013

First Posted

February 21, 2013

Study Start

April 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

May 3, 2013

Record last verified: 2013-04

Locations

AU(1)