Atrial FibrillationNCT01795781
Assays for and Reversal of New Anticoagulants
An observational study of Atrial Fibrillation and Osteoarthritis of the Knee, run by R.P.Herrmann at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Osteoarthritis of the Knee, Osteoarthritis of the Hip
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2012to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Failure to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Keywords
- Anticoagulant measurement, Anticoagulant reversal, Dabigatran, Rivaroxaban
- Medical subject headings
- Atrial Fibrillation, Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Two hours after ingestion of anticoagulant dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- R.P.Herrmann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, R.P.Herrmann, Royal Perth Hospital
- Investigators
- Ross I Baker, MB, BS, Principal investigator, Royal Perth Hospital, Wellington St, Perth, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795781
- Sponsor's protocol ID
- 2011/117
- Status last verified
- Apr 2013
- First submitted
- 14 Feb 2013
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Anticoagulant Assays for New Anticoagulants and Their Reversibility in Vitro
- ClinicalTrials.gov ID
- NCT01795781
- Acronym / sponsor ID
- 2011/117
- Keywords
- Anticoagulant measurement, Anticoagulant reversal, Dabigatran, Rivaroxaban
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- R.P.HerrmannUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Failure to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ross I Baker, MB, BS principal investigator
Royal Perth Hospital, Wellington St, Perth, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Osteoarthritis of the Knee, run by R.P.Herrmann at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to reverse anticoagulant effect in vitro of dabigatran or rivarovaban (time frame: Two hours after ingestion of anticoagulant dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2013.