Femur Fracture Clinical Trial
— STOP-NACOOfficial title:
Assessment the Benefit of a Service Procedure Management of NACO in the Treatment of Fractures of the Upper Extremity of the Femur
NCT number | NCT06220422 |
Other study ID # | CHRD0123 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 26, 2024 |
Est. completion date | April 10, 2024 |
Verified date | June 2024 |
Source | Hôpital NOVO |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 127 |
Est. completion date | April 10, 2024 |
Est. primary completion date | April 10, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 . |
Country | Name | City | State |
---|---|---|---|
France | Anaesthetics department - Hôpital NOVO - Pontoise Site | Pontoise |
Lead Sponsor | Collaborator |
---|---|
Hôpital NOVO |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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