NCT03871283

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

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

January 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

12 months

First QC Date

February 19, 2019

Last Update Submit

August 11, 2020

Conditions

Anticoagulants and Bleeding Disorders

Outcome Measures

Primary Outcomes (1)

  • Ratio of well treated patient

    Ratio of well treated patient

    30 days

Secondary Outcomes (4)

  • bleeding consequence (volume in mL)

    30 days

  • Mortality Consequence

    30 Days

  • Blood Test Consequence

    30 Days

  • Morbidity

    30 days

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patient programed for elective surgery

You may qualify if:

  • Patients over 18 years old
  • Able to consent
  • Taking anticoagulants or antiplatelet drugs in the long term.

You may not qualify if:

  • Incapacitated adults
  • Minor patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ERASME Hospital

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Olivier DURANTEAU, Resident

    ERASME UH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2019

First Posted

March 12, 2019

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

August 12, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

if ask by mail send over

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
at the end of the study during 1 month
Access Criteria
Academic hospital

Locations

BE(1)