broken hip Hip fracture
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >=45 years 2. Diagnosis of hip fracture during working hours with a low-energy mechanism (i.e., falling from standing height) requiring surgery
Exclusion criteria
Exclusion criteria: 1. Patients requiring emergent surgery or emergent interventions for another reason (e.g., subdural hematoma, abdominal pathology requiring urgent laparotomy, acute limb ischemia, other fractures or trauma requiring emergent surgery, necrotising fasciitis, coronary revascularization, pacemaker-implantation) 2. Open hip fracture 3. Bilateral hip fractures 4. Peri-prosthetic fracture 5. Therapeutic anticoagulation not induced by a vitamin K antagonist, unfractionated heparin (e.g., administration of therapeutic LMWH (>6,000 u/24h) in the 24 hours prior to enrolment) or intake of any other non-reversible oral anticoagulant(s) for which there is no reversing agent available 6. Patients on a therapeutic vitamin K antagonist with a history of heparin induced thrombocytopenia (HIT) 7. Patients refusing participation 8. Patients previously enrolled in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is to determine the effect of accelerated medical clearance and accelerated surgery compared to standard care on the 90-day risk of the following two co-primary outcomes: all-cause mortality and major perioperative complications (i.e., a composite of mortality, nonfatal myocardial infarction, nonfatal venous thromboembolism, nonfatal pneumonia, nonfatal sepsis, nonfatal stroke, and nonfatal life-threatening and major bleeding) in patients who have suffered a hip fracture. | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the effect of accelerated medical clearance and accelerated surgery compared to standard care on each of the following individual secondary outcomes at 90 days after randomization:vascular mortality, non-vascular mortality, myocardial infarction, myocardial injury after randomization not meeting the third universal definition of MI 53-55, congestive heart failure, new clinically important atrial fibrillation, stroke, VTE (i.e., pulmonary embolism or proximal deep venous thrombosis), pulmonary embolism, proximal deep venous thrombosis, pneumonia, sepsis, infection, life-threatening bleeding, major bleeding, composite of life-threatening and major bleeding, new residence in a nursing home, and pressure ulcers. We will also inform the effect of accelerated medical clearance and accelerated surgery compared to standard care on delirium within 7 days after randomization. We will also determine the impact of accelerated medical clearance and accelerated surgery compared to standard care at 1 year after randomization on all-cause mortality and separately the composite outcome of total mortality and any of the following nonfatal outcomes: myocardial infarction, VTE, pneumonia, sepsis, stroke, and life-threatening and major bleeding at 1 year after randomization. We will also determine the impact of accelerated medical clearance and accelerated surgery compared to standard care on each of the following individual secondary outcomes 1 year after randomization: vascular mortality, non-vascular mortality, myocardial infarction, congestive heart failure, new clinically important atrial fibrillation, stroke, VTE, pulmonary embolism, proximal deep venous thrombosis, pneumonia, sepsis, infection, life-threatening bleeding, major bleeding, composite of life-threatening and major bleeding, and new residence in a nursing home. To determine the effect of accelerated surgery compared to standard care on each of the following individual tertiary out | — |
Countries
Belgium, Canada, China, Colombia, France, India, Italy, Kenya, Malaysia, Netherlands, Pakistan, Poland, South Africa, Spain, Thailand, United Kingdom, United States of America, Venezuela