NCT06220422

Brief Summary

The purpose of this study is to demonstrate that by allowing patients with an anticoagulant level less than 100 ng/ml to have their fracture managed surgically, will reduce the delay in surgery and therefore the complications associated. It will also demonstrate that there are no more complications with this new management than from remaining with a bleeding fracture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

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

First Submitted

Initial submission to the registry

January 3, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 26, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2024

Completed
Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

1 month

First QC Date

January 3, 2024

Last Update Submit

June 11, 2024

Conditions

Femur Fracture

Keywords

NACOFractureUpper end of the femurDepartment new procedure

Outcome Measures

Primary Outcomes (1)

  • Highlighting of a reduction in the time to surgical management of fracture of the upper end of the femur by adjusting the preoperative threshold for the dosage of of direct-acting oral anticoagulants

    Comparison of time from hospital admission to surgery (in hours) between both groups

    At the end of the study, an average of 1 month

Secondary Outcomes (7)

  • Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on estimated intraoperative blood loss

    At the end of the study, an average of 1 month

  • Description of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on transfusion requirement

    At the end of the study, an average of 1 month

  • Description of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the hospital morbidity

    At the end of the study, an average of 1 month

  • Measure the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the hospital mortality

    At the end of the study, an average of 1 month

  • Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the complications affecting surgical management

    At the end of the study, an average of 1 month

  • +2 more secondary outcomes

Study Arms (2)

Standard Department procedure for managing direct-acting oral anticoagulants

Standard Department procedure for managing direct-acting oral anticoagulants (NACO \< 50 ng/mL) in the management of fractures before September 2021

Procedure: Standard Department procedure for managing direct-acting oral anticoagulants

New Department procedure for managing direct-acting oral anticoagulants

Intervention Description New Department procedure for managing direct-acting oral anticoagulants (NACO \< 100 ng/mL) in the management of fractures after September 2021

Procedure: New Department procedure for managing direct-acting oral anticoagulants

Interventions

Standard Department procedure for managing direct-acting oral anticoagulantsPROCEDURE

Standard Department procedure for managing direct-acting oral anticoagulants (NACO \< 50 ng/mL) in the management of fractures before September 2021

Standard Department procedure for managing direct-acting oral anticoagulants
New Department procedure for managing direct-acting oral anticoagulantsPROCEDURE

New Department procedure for managing direct-acting oral anticoagulants (NACO \< 100 ng/mL) in the management of fractures after September 2021

New Department procedure for managing direct-acting oral anticoagulants

Eligibility Criteria

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

Patients on new anticoagulants undergoing surgery for fracture of the upper end of the femur between 2018 and 2023

You may qualify if:

  • Patients on NACO undergoing surgery for fracture of the upper end of the femur,
  • years and over,
  • Informed patients who did not object.

You may not qualify if:

  • Patients under court protection,
  • Patients under guardianship/curators .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anaesthetics department - Hôpital NOVO - Pontoise Site

Pontoise, 95300, France

Location

MeSH Terms

Conditions

Femoral FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Wounds and InjuriesLeg Injuries

Study Officials

  • Dr Amélie TOUSSAINT

    Hôpital NOVO

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 3, 2024

First Posted

January 24, 2024

Study Start

February 26, 2024

Primary Completion

April 10, 2024

Study Completion

April 10, 2024

Last Updated

June 12, 2024

Record last verified: 2024-06

Locations

FR(1)