- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04755686
Effects of Fast-tracking Geriatric Hip Fracture Patients
Effects of Fast-tracking Hip Fracture Patients in Geriatric Medicine Wards on Complication Incidence and Time of Hospitalization
Study Overview
Detailed Description
Each year about 18000 persons in Sweden suffer from a hip fracture. These people are often among the oldest and have many complicating diseases. The one-year mortality after hip fracture is 20%. Due to the complexity including many comorbidities in these patients, it is of great value that the care of these patients is optimal.
Today, most of the patients with suspected hip fracture in the catchment area of Sahlgrenska University hospital, Gothenburg, are transported directly to the radiology unit. Thereafter, the patient waits in the emergency room (ER) for an othopedic examination before being admitted to primarily a geriatric medicine ward where they wait for the operation. The average waiting time in the ER is today around four hours. The current scientific evidence for fast-tracking hipfracture patients is limited. The aim of our randomized controlled trial is to determine the effect of fast-tracking hip fracture patients at geraitric medicine wards compared to standard care regarding complication rate (primary endpoint), lenght of hospital stay and time to operation (secondary outcomes).
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Gothenburg, Sweden
- Sahlgrenska University hospital, Mölndal
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients with low energy trauma with pain at the hip and/or groin AND
- respiratory frequency: 8-25/minute AND
- saturation: 90% or higher on air AND
- pulse: 50-119 beats per minute AND
- systolic blood pressure: >90 mmHg AND
- level of consciousness: Reaction level scale (RLS) 1 or Glasgow Coma Scale (GCS) 14-15 AND
- plasma-glucose: 3,0-25 mmol/l
Exclusion Criteria:
We will exclude patients based on the following criteria:
- distal status affected
- suspicion of other simultaneous fracture
- suspicion of head trauma or affected consciousness
- suspicion of acute cardiac disease
- signs of acute cardiac ischemia in electrocardiogram
- generalized symtoms, except for pain in the hip
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Fast-tracking at geriatric medicine ward
Fast-tracking hip fracture patients at geriatric medicine ward.
The goal is to optimize the medical care of older hip fracture patients at a geriatric ward and to shorten the time to operation.
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NO_INTERVENTION: Regular admission
Regular admission and care of hip fracture patients at the emergency room prior to surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of complications (composit endpoint of non-fatal major bleeding, pressure ulcer, non-fatal infections, confusion, non-fatal tromboembolic events, all-cause mortality)
Time Frame: at time of discharge from geriatric medicine ward, after four months and after one year
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at time of discharge from geriatric medicine ward, after four months and after one year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Length of hospital stay, time to operation, all-cause mortality, functional ability after discharge, proportion of patients returning to former living, self assessed health status
Time Frame: At time of discharge from geriatric medicine ward, after four months and after one year
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At time of discharge from geriatric medicine ward, after four months and after one year
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Collaborators and Investigators
Investigators
- Principal Investigator: Mattias Lorentzon, MD, PhD, Geriatric Medicine, Sahlgrenska University Hospital, Mölndal
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- dnr 154-13
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