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HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) Trial

HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) Trial - HipATTACK

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48891
Enrollment
35
Registered
2019-10-01
Start date
2018-01-18
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

broken hip Hip fracture

Interventions

Patients randomized to accelerated care will undergo medical clearance by a dedicated HIP ATTACK medical specialist (e.g., medical specialist would include, internal medicine specialist, geriatricia
Accelerated care
Hip Fracture

Sponsors

Population Health Research Institute
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)