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Evaluation of a strategy to shorten the time to surgery in patients on antiplatelet therapy with a proximal femur fracture (AFFEcT Study): Study protocol for a multicenter randomized controlled clinical trial.

ABSTRACT: INTRODUCTION:Patients with femur fracture benefit from early surgery. Recent reports suggest that regional anesthesia may be superior to general anesthesia in these patients. Early surgery under spinal anesthesia could be performed safely by determining platelet function in patients receiving antiplatelet agents. METHODS:Multicenter, randomized, open-label, parallel clinical trial expected to include 156 patients ? 18 years of age under chronic treatment with antiplatelet agents who develop a proximal femur fracture. EXCLUSION CRITERIA:presence of multiple or pathological fractures, current treatment with vitamin K antagonists or new oral anticoagulants, and congenital or acquired coagulopathy.Patients will be randomized to eitherThe primary endpoint is time (hours) from admission to surgery. Secondary endpoints include: platelet function; postoperative bleeding; medical-surgical complications; perioperative and 1-year mortality; quality of life; length of hospital stay; cost-effectiveness; and cost-utility. Follow-up assessments will be performed during hospital admission and at 1, 6, and 12 months after surgery. POTENTIAL IMPACT OF THE STUDY:The determination of platelet function at admission to the emergency department in patients with femoral fracture receiving antiplatelet therapy may permit earlier surgery under spinal anesthesia, thus shortening the hospital stay and reducing the risk of complications. These advantages associated with early surgery could positively impact patient well-being and also reduce treatment-related healthcare costs. ETHICS AND DISSEMINATION:The study has been approved by the ethics committees at all participating centers. Their results will be disseminated in congresses and published in peer reviewed journals.

SUBMITTER: Anaya R

PROVIDER: S-EPMC6531028 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Evaluation of a strategy to shorten the time to surgery in patients on antiplatelet therapy with a proximal femur fracture (AFFEcT Study): Study protocol for a multicenter randomized controlled clinical trial.

Rafael Anaya A Mireia Rodriguez R José María Gil G Victoria Moral M Angélica Millan M Noèlia Vilalta V Erica Claudia C Rosa María Antonijoan A Francesca Reguant R Patricia Guilabert G Domingo Blanco B José Mateo M Angela Merchán-Galvis MG Maria Jose Martinez-Zapata MZ

Medicine 20190501 19

<h4>Introduction</h4>Patients with femur fracture benefit from early surgery. Recent reports suggest that regional anesthesia may be superior to general anesthesia in these patients. Early surgery under spinal anesthesia could be performed safely by determining platelet function in patients receiving antiplatelet agents.<h4>Methods</h4>Multicenter, randomized, open-label, parallel clinical trial expected to include 156 patients ≥ 18 years of age under chronic treatment with antiplatelet agents w ...[more]

PMID: 31083195

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Project description:BackgroundAntiplatelet medication has been frequently performed in elderly patients with hip fracture, because of comorbidities. This observational cohort study was to evaluate the effect of continuous perioperative antiplatelet medication on the outcomes after cephalomedullary nailing (CMN) in elderly patients with a proximal femur fracture.MethodsOne hundred and sixty-two consecutive patients aged ≥70 years undergoing CMN for proximal femur fracture between January 2015 and January 2017 were recruited. Of the 162 patients, 47 (study group) taking antiplatelets preoperatively due to comorbidities were compared with 107 (control group) who were not on antiplatelets. 8 patients taking anticoagulant medication were excluded. Postoperative hemoglobin (Hb) and hematocrit (Hct) levels, transfusion amount and estimated blood loss (EBL), occurrence of venous thromboembolism (VTE) and delirium, intensive care unit (ICU) admission, complications, length of hospital stay, readmission, and in-hospital and 1-year mortalities were measured and compared between the two groups.ResultsA higher number of patients in the study group had concomitant cardiovascular (p = 0.006) and endocrinologic (p = 0.004) diseases, received perioperative transfusion (p = 0.003), and were admitted to ICU postoperatively (p = 0.014). However, there were no significant differences in postoperative Hb and Hct levels, EBL, length of hospital stay, and the incidences of VTE and delirium between the two groups. In addition, in-hospital and 1-year mortalities as well as postoperative complications showed no significant differences between both groups.ConclusionsCMN can be performed without delay in elderly patients with proximal femoral fracture receiving antiplatelet therapy prior to admission without discontinuing antiplatelets, and is as safe as in patients who are not on antiplatelet medication. However, more caution is required with respect to transfusions and ICU care after surgery in these patients.

Project description:We have characterised 997 hip fracture patients from a representative 45 Spanish hospitals, and followed them up prospectively for up to 4 months. Despite suboptimal surgical delays (average 59.1 hours), in-hospital mortality was lower than in Northern European cohorts. The secondary fracture prevention gap is unacceptably high at 85%.PurposeTo characterise inpatient care, complications, and 4-month mortality following a hip or proximal femur fracture in Spain.MethodsDesign: prospective cohort study. Consecutive sample of patients ??50 years old admitted in a representative 45 hospitals for a hip or proximal femur fragility fracture, from June 2014 to June 2016 and followed up for 4 months post-fracture. Patient characteristics, site of fracture, in-patient care (including secondary fracture prevention) and complications, and 4-month mortality are described.ResultsA total of 997 subjects (765 women) of mean (standard deviation) age 83.6 (8.4) years were included. Previous history of fracture/s (36.9%) and falls (43%) were common, and 10-year FRAX-estimated major and hip fracture risks were 15.2% (9.0%) and 8.5% (7.6%) respectively. Inter-trochanteric (44.6%) and displaced intra-capsular (28.0%) were the most common fracture sites, and fixation with short intramedullary nail (38.6%) with spinal anaesthesia (75.5%) the most common procedures. Surgery and rehabilitation were initiated within a mean 59.1 (56.7) and 61.9 (55.1) hours respectively, and average length of stay was 11.5 (9.3) days. Antithrombotic and antibiotic prophylaxis were given to 99.8% and 98.2% respectively, whilst only 12.4% received secondary fracture prevention at discharge. Common complications included delirium (36.1 %) and kidney failure (14.1%), with in-hospital and 4-month mortality of 2.1% and 11% respectively.ConclusionsDespite suboptimal surgical delay, post-hip fracture mortality is low in Spanish hospitals. The secondary fracture prevention gap is unacceptably high at >?85%, in spite of virtually universal anti-thrombotic and antibiotic prophylaxis.

Project description:BackgroundHip fractures are a common and costly health problem, resulting in significant morbidity and mortality, as well as high costs for healthcare systems, especially for the elderly. Implementing surgical preventive strategies has the potential to improve the quality of life and reduce the burden on healthcare resources, particularly in the long term. However, there are currently limited guidelines for standardizing hip fracture prophylaxis practices.MethodsThis study used a cost-effectiveness analysis with a finite-state Markov model and cohort simulation to evaluate the primary and secondary surgical prevention of hip fractures in the elderly. Patients aged 60 to 90 years were simulated in two different models (A and B) to assess prevention at different levels. Model A assumed prophylaxis was performed during the fracture operation on the contralateral side, while Model B included individuals with high fracture risk factors. Costs were obtained from the Centers for Medicare & Medicaid Services, and transition probabilities and health state utilities were derived from available literature. The baseline assumption was a 10% reduction in fracture risk after prophylaxis. A sensitivity analysis was also conducted to assess the reliability and variability of the results.ResultsWith a 10% fracture risk reduction, model A costs between $8,850 and $46,940 per quality-adjusted life-year ($/QALY). Additionally, it proved most cost-effective in the age range between 61 and 81 years. The sensitivity analysis established that a reduction of ≥ 2.8% is needed for prophylaxis to be definitely cost-effective. The cost-effectiveness at the secondary prevention level was most sensitive to the cost of the contralateral side's prophylaxis, the patient's age, and fracture treatment cost. For high-risk patients with no fracture history, the cost-effectiveness of a preventive strategy depends on their risk profile. In the baseline analysis, the incremental cost-effectiveness ratio at the primary prevention level varied between $11,000/QALY and $74,000/QALY, which is below the defined willingness to pay threshold.ConclusionDue to the high cost of hip fracture treatment and its increased morbidity, surgical prophylaxis strategies have demonstrated that they can significantly relieve the healthcare system. Various key assumptions facilitated the modeling, allowing for adequate room for uncertainty. Further research is needed to evaluate health-state-associated risks.

Dataset Information

Evaluation of a strategy to shorten the time to surgery in patients on antiplatelet therapy with a proximal femur fracture (AFFEcT Study): Study protocol for a multicenter randomized controlled clinical trial.

Publications

Evaluation of a strategy to shorten the time to surgery in patients on antiplatelet therapy with a proximal femur fracture (AFFEcT Study): Study protocol for a multicenter randomized controlled clinical trial.

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