HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial

Официальное название

HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 (HIP ATTACK-2) Trial

Обзор

The HIP ATTACK-2 trial is a multicentre, international, parallel group randomized controlled trial to determine whether accelerated surgery for hip fracture in patients with acute myocardial injury is superior to standard care in reducing death at 90 days after randomization. The trial will also assess secondary outcomes at 90 days after randomization: inability to independently walk 3 metres, time to first mobilization (first standing and first full weight bear), composite and individual assessment of major complications (e.g., mortality, non-fatal myocardial infarction, acute congestive heart failure, and stroke), delirium, length of stay, pain, and quality of life.

Вмешательства

• Другое Accelerated medical clearance and surgery
  Rapid medical clearance with targeted arrival to the operating room within 6 hours of eligibility criteria criteria met.

Первичные конечные точки

• All cause mortality [Срок оценки: Within 90 days post randomization]

Вторичные конечные точки (10)

• Ability to independently walk 3 meters [Срок оценки: Within 90 days post randomization]
• Composite of major complications [Срок оценки: Within 90 days post randomization]
• Vascular mortality [Срок оценки: Within 90 days post randomization]
• Nonvascular mortality [Срок оценки: Within 90 days post randomization]
• Myocardial Infarction [Срок оценки: Within 90 days post randomization]
• Acute Congestive Heart Failure [Срок оценки: Within 90 days post randomization]
• Stroke [Срок оценки: Within 90 days post randomization]
• Time from randomization to hospital discharge [Срок оценки: Within 90 days post randomization]
• Delirium [Срок оценки: Within 7 days and 90 days post randomization]
• Moderate to severe pain [Срок оценки: Within 7 days and 90 days post randomization]

Критерии участия

Критерии включения

• age ≥45 years;
• diagnosis of hip fracture during working hours with a low-energy mechanism requiring surgery;
• troponin elevation ( at least one troponin measurement above the upper limit of normal occurring from the time of hip fracture to the time of randomization); and
• informed consent.

Критерии исключения

• taking a therapeutic dose of an anticoagulant for which no reversing agent is available and the anesthesiologist or surgeon believe surgery within 6 hours of eligibility criteria met would not be safe;
• patients on a therapeutic vitamin K antagonist with a history of heparin induced thrombocytopenia (HIT);
• patients with peri-prosthetic fracture, open fracture or bilateral fractures;
• patients requiring an emergency surgery for another reason (e.g., subdural hematoma);
• patients with acute myocardial infarction deemed to be clinically unstable, with a mechanical complication (i.e., acute papillary muscle rupture, ventricular septal defect), ST elevation myocardial infarction, or cardiogenic shock;
• patients refusing consent; or
• patients previously enrolled in HIP ATTACK-2.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 19 центров

• Chandler Regional Medical Center — Chandler
• The Regents of the University of California — Davis
• Yale New Haven Hospital — New Haven
• Emory University at Grady Memorial Hospital — Atlanta
• University of Maryland — Baltimore
• Sinai Hospital of Baltimore — Baltimore
• Tufts Medical Center — Boston
• Lahey Hospital and Medical Center — Burlington
• … и ещё 11 центров

Испания · 10 центров

• Hospital Universitari Sagrat Cor — Barcelona
• Hospital Universitari Vall d'Hebron — Barcelona
• Hospital Clinic of Barcelona — Barcelona
• Hospital de la Santa Creu I Sant Pau — Barcelona
• Hospital Universitari Parc Tauli — Sabadell
• Hospital Sant Camil — Sant Pere de Ribes
• Hospital Universitario Mutua de Terrassa — Terrassa
• Hospital Costa del Sol — Marbella
• … и ещё 2 центра

Канада · 7 центров

• University of Alberta Hospital — Edmonton
• St. Joseph's Healthcare Hamilton — Hamilton
• Juravinski Hospital — Hamilton
• Victoria Hospital — London
• Markham Stouffville Hospital — Markham
• Ottawa General Hospital — Ottawa
• CISSS de Laval — Laval

Пакистан · 7 центров

• Maroof International Hospital — Islamabad
• Shifa International Hospitals Ltd. — Islamabad
• Hayat Abad Medical Complex — Peshawar
• Ghurki Trust Teaching Hospital — Lahore
• Combined Military Hospital — Rawalpindi
• Aga Khan University — Karachi
• Indus Hospital & Health Network — Karachi

Индия · 5 центров

• Bangalore Baptist Hospital — Bangalore
• Government TD Medical College — Alappuzha
• Government Medical College — Trivandrum
• All India Institute of Medical Sciences (AIIMS) — New Delhi
• JIPMER — Puducherry

Италия · 4 центра

• Hospital of Perugia — Perugia
• Galliera Hospital — Genova
• Ospedale San Raffaele S.r.l. — Milan
• Ospedale Galeazzi SpA — Milan

Чили · 2 центра

• Pontifica Universidad Catolica de Chile — Santiago
• Clinica Santa Maria — Santiago

Финляндия · 2 центра

• South Karelia Central Hospital — Lappeenranta
• Tampere University Hospital — Tampere

Мексика · 2 центра

• Christus Muguerza del Parque — Chihuahua City
• Cruz Verde Guadalajara — Guadalajara

Нидерланды · 2 центра

• Deventer Hospital — Deventer
• Stichting OLVG — Amsterdam

ЮАР · 2 центра

• Stellenbosch University - Tygerberg Hospital — Cape Town
• Groote Schuur Hospital — Cape Town

Австралия · 1 центр

• The John Hunter Hospital — New Lambton Heights

Бельгия · 1 центр

• Cliniques Universitaires Saint Luc - University Catholic of Louvain — Woluwe-Saint-Lambert

Бразилия · 1 центр

• University of São Paulo — São Paulo

Гонконг · 1 центр

• Queen Mary Hospital — Гонконг

Малайзия · 1 центр

• University of Malaya Medical Centre — Kuala Lumpur

Nepal · 1 центр

• B and B Hospital — Lalitpur

Польша · 1 центр

• SPZOZ Myslenice — Myślenice

Саудовская Аравия · 1 центр

• King Faisal Specialist Hospital — Riyadh

Идентификаторы

NCT: NCT04743765 · v2.0_20230608

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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