Multicentre, international, parallel group randomized controlled trial among patients with hip fracture to determine the effect of accelerated medical clearance and accelerated surgery compared to standard care on the 30 day risk of major perioperative complicatio

Not Applicable

Completed

• Conditions: Health Condition 1: S790- Physeal fracture of upper end of femur

• Registration Number: CTRI/2017/06/008789
• Lead Sponsor: Population Health Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-12-31
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 471

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

1. Patients requiring emergent surgery or an emergent intervention

(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 warfarin or

unfractionated heparin, (e.g., any administration of therapeutic

LMWH [ >6,000 u/24h] in the 24 hours prior to enrolment, or any

intake of Dabigatran, Apixaban, Rivaroxaban, or Edoxaban);

6. Patients on a therapeutic vitamin K antagonist with a history of

heparin induced thrombocytopenia;

7. Patients refusing participation; or

8. Patients previously enrolled in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of major perioperative complications (i.e., mortality, nonfatal <br/ ><br>myocardial infarction, nonfatal pulmonary embolism, nonfatal pneumonia, <br/ ><br>nonfatal sepsis, nonfatal stroke, nonfatal life-threatening bleeding, and <br/ ><br>major bleeding) at 30 days and 1 year after randomization.Timepoint: 30 days and 1 year after randomization.

Secondary Outcome Measures

Name	Time	Method
All-cause mortality,vascular non-vascular mortality,MI,CHF,new clinically important AF,PE,DVT,pneumonia,sepsis, infection,major bleeding,AKI, peri-prosthetic fracture, prosthetic hip dislocation, implant failure, hip re-operation,time to 1st mobilization,length of hospital stay,critical care stay,rehabilitation stay,new residence in a nursing home, new pressure ulcers,incisional pain, and Functional Independence Measure (FIMâ?¢) motor domain its mobility,locomotion subscores, SF-36 scoreTimepoint: 30 days and 1 year after randomization