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Completed

NCT Number: NCT06220422

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

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.

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Key information

Conditions

Femur Fracture Femoral Fractures Fractures, Bone Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Anaesthetics department - Hôpital NOVO - Pontoise Site

Pontoise, 95300, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Standard Department procedure for managing direct-acting oral anticoagulants

Procedure

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

Procedure

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

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

    Time frame: At the end of the study, an average of 1 month

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

Secondary outcomes

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

    Time frame: At the end of the study, an average of 1 month

    Comparison on the amount of blood lost (mL) between both groups

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

    Time frame: At the end of the study, an average of 1 month

    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.

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

    Time frame: At the end of the study, an average of 1 month

    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

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

    Time frame: At the end of the study, an average of 1 month

    Comparison on the number of deaths in each group.

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

    Time frame: At the end of the study, an average of 1 month

    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)

  6. Measure of the impact of the department's new strategy (NACO threshold < 100 ng/mL) on the degree of dependence due to surgical management

    Time frame: At the end of the study, an average of 1 month

    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.

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

    Time frame: At the end of the study, an average of 1 month

    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)

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Official study title

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

Acronym: STOP-NACO

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 24, 2024
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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