Anticoagulation and Antiplatelet Management During Perioperative Period

Anticoagulants and Bleeding Disorders Clinical Trial

— OMAHA  

Official title:

Anticoagulation and Antiplatelet Management During Perioperative Period : a Daily Practice Cohort Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03871283
• Other study ID #: OMAHA
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2020
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2400
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients over 18 years old

• Able to consent

• Taking anticoagulants or antiplatelet drugs in the long term.

Exclusion Criteria:

• Incapacitated adults

• Minor patients

Related Conditions & MeSH terms

• Anticoagulants and Bleeding Disorders
• Blood Coagulation Disorders
• Hemostatic Disorders

Locations

Country	Name	City	State
Belgium	ERASME Hospital	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of well treated patient	Ratio of well treated patient	30 days
Secondary	bleeding consequence (volume in mL)	bleeding consequence (volume in mL)	30 days
Secondary	Mortality Consequence	percentage of death	30 Days
Secondary	Blood Test Consequence	deviation in percentage on INR	30 Days
Secondary	Morbidity	percentage of rehospitalisation	30 days