Assessment of a Procedure for Managing Oral Anticoagulants (NACO) in the Management of Fractures (STOP-NACO)

Assessment the Benefit of a Service Procedure Management of NACO in the Treatment of Fractures of the Upper Extremity of the Femur

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.

Study Overview

• Status: Completed
• Conditions: Femur Fracture
• Intervention / Treatment: Procedure: Standard Department procedure for managing direct-acting oral anticoagulants; Procedure: New Department procedure for managing direct-acting oral anticoagulants

Detailed Description

Fracture of the upper extremity of the femur are constantly on the increase and represent a public health issue in a population with increasing life expectancy. In the majority of cases, this fracture requires rapid surgical treatment, ideally within 48 hours, before complications, associated with the supine position, appear. A prolonged surgical delay is responsible for multiple complications and increase mortality in a potentially comorbid and fragile population.

Oral anticoagulants (NACOs) are now widely used in general population for cardiovascular diseases, such as non-valvular atrial fibrillation or thrombo-embolic events. Their activity and circulation rate are assessed by an Anti-Xa assay. The current recommendation for scheduled surgery is an assay with an anti-Xa activity of less than 50 ng/mL.

The acquisition of this assay and the wait for a decrease in anti-Xa activity are currently a factor of lengthening the surgical delay leading to proposal a new dosage. By offering the possibility of surgical management with an anti-Xa activity of less than 100 ng/ml, the purpose is to demonstrate a reduction in surgical delay (less than 48 hours) and associated complications. One of the secondary purposes is also to demonstrate that there are no more intra and post-operative complications with this new protocol.

• Study Type: Observational
• Enrollment (Actual): 127

Contacts and Locations

Study Locations

• France
  • Pontoise, France, 95300
    • Anaesthetics department - Hôpital NOVO - Pontoise Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria :

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

Exclusion Criteria :

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Standard Department procedure for managing direct-acting oral anticoagulants (NACO < 50 ng/mL) in the management of fractures before September 2021
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; New Department procedure for managing direct-acting oral anticoagulants (NACO < 100 ng/mL) in the management of fractures after September 2021

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on estimated intraoperative blood loss	Comparison on the amount of blood lost (mL) between both groups	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	The impact on transfusion requirements between both groups is evaluate on the following items : Packed red blood cells,; Fresh frozen plasma,; Unit concentrate of platelets,; 4-factor prothrombin complex concentrate.	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	The impact on Hospital morbidity between both groups is evaluate on the following complications : Infectious complications (surgical site infection, nosocomial infections: urinary, pneumonia, others),; Thromboembolic complications (pulmonary embolism, deep vein thrombosis),; Cardiovascular complications (decompensation of heart failure, Acute pulmonary oedema, ACS),; Post-operative haemorrhagic complications (surgical site haematoma requiring treatment),; 30-day readmission	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	Comparison on the number of deaths in each group.	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 factors affecting surgical management	The impact on the factors affecting surgical management between both groups is evaluate on the following item : - Day of admission to care (weekend/holiday/on-call day)	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	The impact on the factors affecting surgical management between both groups is evaluate on the following item : - Complications of the supine position (bedsores, etc.) and those related to the field (confusion, physical restraint indwelling catheter, stay in intensive care, resumption walking /chair, delay in returning home, Follow-up care and rehabilitation (SSR), geriatric assessment, nutritional management)	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 degree of dependence due to surgical management	The impact on the factors affecting surgical management between both groups is evaluate on the following item : - Degree of dependence according to the Katz evaluation scale, The KATZ scale is used to determine the degree of dependency of patients. It consists of a questionnaire assessing their abilities in 6 areas of daily life. For each area, the response varies between 4 scores ranging from no assistance to the need for total assistance.	At the end of the study, an average of 1 month

Collaborators and Investigators

• Sponsor: Hôpital NOVO
• Investigators: Principal Investigator: Dr Amélie TOUSSAINT, Hôpital NOVO

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Actual): April 10, 2024
• Study Completion (Actual): April 10, 2024

Study Registration Dates

• First Submitted: January 3, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Fracture; NACO; Upper end of the femur; Department new procedure
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Factor Xa Inhibitors
• Other Study ID Numbers: CHRD0123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No