Anticoagulants and Bleeding DisordersOMAHANCT03871283
Anticoagulation and Antiplatelet Management During Perioperative Period
An observational study of Anticoagulants and Bleeding Disorders, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
the investigators hypothesize that patients do not understand these therapies, and that they are poorly undertaken. In some cases, the anesthesiologist does not understand correctly the indication of the treatment due to lack of information and therefore does not know how to adapt it to the medical situation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anticoagulants and Bleeding Disorders
- How many people
- 2,400 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2019to 31 Dec 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patient programed for elective surgery
Who may be able to join
- Patients over 18 years old
- Able to consent
- Taking anticoagulants or antiplatelet drugs in the long term.
Who cannot join
- Incapacitated adults
- Minor patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anticoagulation and Antiplatelet Management During Perioperative Period : a Daily Practice Cohort Prospective Study
the investigators hypothesize that patients do not understand these therapies, and that they are poorly undertaken. In some cases, the anesthesiologist does not understand correctly the indication of the treatment due to lack of information and therefore does not know how to adapt it to the medical situation.
Read the detailed description
the investigators hypothesize that patients do not understand these therapies, and that they are poorly undertaken. In some cases, the anesthesiologist does not understand correctly the indication of the treatment due to lack of information and therefore does not know how to adapt it to the medical situation.
the investigators want to investigate these transitions: how were they understood by patients, how were they performed, and how does this affect surgery, postoperative morbidity and mortality?
Anticoagulation for prevention of thromboembolic events will not be studied in this study.
The anesthesia team will not be particularly trained in anticoagulants and antiplatelets management to be close to actual care. In the Hospital the investigators have a guide written in 2013 in order to describe all the cases possible. The "control/ goal group" will be the patients who have undertaken strictly the protocol described for their cases in the guide.
- Conditions
- Anticoagulants and Bleeding Disorders
- Medical subject headings
- Hemostatic Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of well treated patient
Ratio of well treated patient
Measured: 30 days
Secondary outcomes (4)
bleeding consequence (volume in mL)
bleeding consequence (volume in mL)
Measured: 30 days
Mortality Consequence
percentage of death
Measured: 30 Days
Blood Test Consequence
deviation in percentage on INR
Measured: 30 Days
Morbidity
percentage of rehospitalisation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulants and Bleeding DisordersStudies 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
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier DURANTEAU, Resident, Principal investigator, ERASME UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871283
- Sponsor's protocol ID
- OMAHA
- Acronym
- OMAHA
- Status last verified
- Aug 2020
- First submitted
- 19 Feb 2019
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: if ask by mail send over
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticoagulation and Antiplatelet Management During Perioperative Period : a Daily Practice Cohort Prospective Study
- ClinicalTrials.gov ID
- NCT03871283
- Acronym / sponsor ID
- OMAHA / OMAHA
- Conditions
- Anticoagulants and Bleeding Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 12 Mar 2019 (actual)
- 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.
the investigators hypothesize that patients do not understand these therapies, and that they are poorly undertaken. In some cases, the anesthesiologist does not understand correctly the indication of the treatment due to lack of information and therefore does not know how to adapt it to the medical situation.
Detailed description
the investigators hypothesize that patients do not understand these therapies, and that they are poorly undertaken. In some cases, the anesthesiologist does not understand correctly the indication of the treatment due to lack of information and therefore does not know how to adapt it to the medical situation.
the investigators want to investigate these transitions: how were they understood by patients, how were they performed, and how does this affect surgery, postoperative morbidity and mortality?
Anticoagulation for prevention of thromboembolic events will not be studied in this study.
The anesthesia team will not be particularly trained in anticoagulants and antiplatelets management to be close to actual care. In the Hospital the investigators have a guide written in 2013 in order to describe all the cases possible. The "control/ goal group" will be the patients who have undertaken strictly the protocol described for their cases in the guide.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patient programed for elective surgery
Key inclusion criteria (3 listed)
- Patients over 18 years old
- Able to consent
- Taking anticoagulants or antiplatelet drugs in the long term.
Key exclusion criteria (2 listed)
- Incapacitated adults
- Minor patients
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
Ratio of well treated patient
Time frame: 30 days
Ratio of well treated patient
4 secondary outcomes
bleeding consequence (volume in mL)
Time frame: 30 days
Mortality Consequence
Time frame: 30 Days
Blood Test Consequence
Time frame: 30 Days
Morbidity
Time frame: 30 days
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 12 Aug 2020.
- Individual participant dataSharing planned: Yes. if ask by mail send over
Related trials for Anticoagulants and Bleeding Disorders
RecruitingPhase 3
Thrombolysis in Factor Xa-inhibitors Trial
Stroke, Stroke (in Patients With Atrial Fibrillation)
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
RecruitingPhase 3
Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
Blood Loss, Surgical, Coagulation Disorder
Enrolling by invitationPhase 4
LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic Oncology
Sarcoma, Soft Tissue Sarcoma
RecruitingObservational study
Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis in Vietnam
Cerebral Venous Thrombosis
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.
Olivier DURANTEAU, Resident principal investigator
ERASME UH
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 Anticoagulants and Bleeding Disorders, run by Erasme University Hospital at 1 site in Belgium.
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 3 inclusion and 2 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 12 Aug 2020. 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 Belgium. 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?
Ratio of well treated patient (time frame: 30 days). 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 12 Aug 2020.