Hip FractureNCT04755686
Effects of Fast-tracking Geriatric Hip Fracture Patients
A study testing Fast-tracking in people with Hip Fracture, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether fast-tracking hip fracture patients to geriatric medicine wards, as opposed to standard care at the emergency room, results in less complications and shorter hospitalization for the patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- Fast-tracking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2013to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Fast-tracking Hip Fracture Patients in Geriatric Medicine Wards on Complication Incidence and Time of Hospitalization
The purpose of this study is to determine whether fast-tracking hip fracture patients to geriatric medicine wards, as opposed to standard care at the emergency room, results in less complications and shorter hospitalization for the patients.
Read the 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).
- Conditions
- Hip Fracture
- Being tested
- Fast-tracking
- Keywords
- hip fracture, fast-tracking, complications
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast-trackingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Fast-tracking at geriatric medicine ward | Experimental | 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. Receives: Procedure: Fast-tracking |
| Regular admission | No intervention | Regular admission and care of hip fracture patients at the emergency room prior to surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications (composit endpoint of non-fatal major bleeding, pressure ulcer, non-fatal infections, confusion, non-fatal tromboembolic events, all-cause mortality)
Measured: at time of discharge from geriatric medicine ward, after four months and after one year
Secondary outcomes (1)
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
Measured: At time of discharge from geriatric medicine ward, after four months and after one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study startJun 2013
- Primary completionJun 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mattias Lorentzon, Sahlgrenska University Hospital
- Investigators
- Mattias Lorentzon, MD, PhD, Principal investigator, Geriatric Medicine, Sahlgrenska University Hospital, Mölndal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755686
- Sponsor's protocol ID
- dnr 154-13
- Status last verified
- Feb 2021
- First submitted
- 10 Jun 2013
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fast-tracking Hip Fracture Patients in Geriatric Medicine Wards on Complication Incidence and Time of Hospitalization
- ClinicalTrials.gov ID
- NCT04755686
- Acronym / sponsor ID
- dnr 154-13
- Conditions
- Hip Fracture
- Keywords
- hip fracture, fast-tracking, complications
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether fast-tracking hip fracture patients to geriatric medicine wards, as opposed to standard care at the emergency room, results in less complications and shorter hospitalization for the patients.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast-tracking at geriatric medicine ward | Experimental | Procedure: Fast-trackingFast-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. |
| Regular admission | No intervention | –Regular admission and care of hip fracture patients at the emergency room prior to surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast-tracking | Procedure or surgery | Fast-tracking at geriatric medicine ward |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mattias Lorentzon, MD, PhD principal investigator
Geriatric Medicine, Sahlgrenska University Hospital, Mölndal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast-tracking in people with Hip Fracture, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.