Hip FracturesNCT04771364
Impact of "ASAP" Multidisciplinary Optimization Care Protocol on Clinical Outcome in Elderly Inpatients for Hip Fracture
An observational study of Hip Fractures, run by University of Liege at 1 site in Belgium.
Trial summary
To compare the impact of ASAP protocol (geriatric advice, early surgery, loco-regional anesthesia and pharmacological adaptation) on elderly patients with hip fracture and clinical outcome. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- ASAP care's protocol
- How many people
- 800 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2017to 31 Dec 2022
- Phase
- Observational
- 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
Study population: Elderly patients >65 years old with hip fracture
Who may be able to join
- Over 65 years old patients with hip fractures between January 1st 2017 and December 31th 2022
Who cannot join
- Fracture without indication for surgery
- Death before surgery
- Intensive care's or polytrauma patients (> 2 fracture sites) or under pharmacological coma needed before and after surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of "ASAP" Multidisciplinary Optimization Care Protocol on Clinical Outcome in Elderly Inpatients for Hip Fracture: Retrospective Cohort Study
To compare the impact of ASAP protocol (geriatric advice, early surgery, loco-regional anesthesia and pharmacological adaptation) on elderly patients with hip fracture and clinical outcome.
Read the detailed description
Retrospective double cohort analysis for ASA physical status 1, 2 and 3 elderly patients >65 years old, scheduled to undergo surgery for hip fracture between January 1st 2017 and December 31st 2022.
The investigator want to confirm the better outcome on 30-days mortality after surgery in patients where the ASAP protocol was applied, starting from 1 January 2020.
ASAP protocol follow the latest international guidelines about hip fracture in elderly patient. The investigator focuses the research about the impact of ASAP protocol on clinical outcome: geriatrician's advice, impact of loco-regional techniques on intra-operative and postoperative pain control, chronic pharmacological therapy's adaptation and 30-days postoperative mortality.
- Conditions
- Hip Fractures
- Being tested
- ASAP care's protocol
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASAP care's protocolOther
Early geriatrician's advice, prefer locoregional anesthesia techniques where possible, early surgical therapy and medical adaptation on chronic patient's therapy (in particular with regard to sedative, anticholinergic and psychotropic drugs).
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Patients aged >65 years old scheduled for hip fracture between January 1st 2017 and December 31th 2019. Standard anesthesiology cares were performed, as usual in our hospital institution. | |
| ASAP cohort | Patients aged >65 years old scheduled for hip fracture between January 1st 2020 and December 31th 2022.
Standard anesthesiology cares were performed, as usual in our hospital institution, but the investigator focused the attention on these cares' adaptation: early geriatrician's advice, prefer locoregional anesthesia techniques where possible, early surgical therapy and medical adaptation on chronic therapy. Receives: Other: ASAP care's protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Neurological, cardiovascular, pulmonary, renal, infectious and gastrointestinal complications after surgery.
Measured: 7 days
Secondary outcomes (2)
Days of hospitalisation
Total hospitalisation days
Measured: 30 days
30-days postoperative mortality
Mortality 1 month after surgery
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Jan 2017
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean François Brichant, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771364
- Sponsor's protocol ID
- ASAP
- Status last verified
- Jan 2023
- First submitted
- 22 Feb 2021
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borges FK, Bhandari M, Patel A, Avram V, Guerra-Farfan E, Sigamani A, Umer M, Tiboni M, Adili A, Neary J, Tandon V, Sancheti PK, Lawendy A, Jenkinson R, Ramokgopa M, Biccard BM, Szczeklik W, Wang CY, Landoni G, Forget P, Popova E, Wood G, Nabi Nur A, John B, Sleczka P, Feibel RJ, Balaguer-Castro M, Deheshi B, Winemaker M, de Beer J, Kolesar R, Teixidor-Serra J, Tomas-Hernandez J, McGillion M, Shanthanna H, Moppett I, Vincent J, Pettit S, Harvey V, Gauthier L, Alvarado K, Devereaux PJ. Rationale and design of the HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) Trial: a protocol for an international randomised controlled trial evaluating early surgery for hip fracture patients. BMJ Open. 2019 May 1;9(4):e028537. doi: 10.1136/bmjopen-2018-028537.
PubMed 31048449Matsuo M, Yamagami T, Higuchi A. Impact of age on postoperative complication rates among elderly patients with hip fracture: a retrospective matched study. J Anesth. 2018 Jun;32(3):452-456. doi: 10.1007/s00540-018-2494-8. Epub 2018 Apr 16.
PubMed 29663067
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of "ASAP" Multidisciplinary Optimization Care Protocol on Clinical Outcome in Elderly Inpatients for Hip Fracture: Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04771364
- Acronym / sponsor ID
- ASAP
- Conditions
- Hip Fractures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 25 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.
To compare the impact of ASAP protocol (geriatric advice, early surgery, loco-regional anesthesia and pharmacological adaptation) on elderly patients with hip fracture and clinical outcome.
Detailed description
Retrospective double cohort analysis for ASA physical status 1, 2 and 3 elderly patients >65 years old, scheduled to undergo surgery for hip fracture between January 1st 2017 and December 31st 2022.
The investigator want to confirm the better outcome on 30-days mortality after surgery in patients where the ASAP protocol was applied, starting from 1 January 2020.
ASAP protocol follow the latest international guidelines about hip fracture in elderly patient. The investigator focuses the research about the impact of ASAP protocol on clinical outcome: geriatrician's advice, impact of loco-regional techniques on intra-operative and postoperative pain control, chronic pharmacological therapy's adaptation and 30-days postoperative mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | – | –Patients aged >65 years old scheduled for hip fracture between January 1st 2017 and December 31th 2019. Standard anesthesiology cares were performed, as usual in our hospital institution. |
| ASAP cohort | – | Other: ASAP care's protocolPatients aged >65 years old scheduled for hip fracture between January 1st 2020 and December 31th 2022. Standard anesthesiology cares were performed, as usual in our hospital institution, but the investigator focused the attention on these cares' adaptation: early geriatrician's advice, prefer locoregional anesthesia techniques where possible, early surgical therapy and medical adaptation on chronic therapy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients >65 years old with hip fracture
Key inclusion criteria (1 listed)
- Over 65 years old patients with hip fractures between January 1st 2017 and December 31th 2022
Key exclusion criteria (3 listed)
- Fracture without indication for surgery
- Death before surgery
- Intensive care's or polytrauma patients (> 2 fracture sites) or under pharmacological coma needed before and after surgery.
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 |
|---|---|---|
| ASAP care's protocolEarly geriatrician's advice, prefer locoregional anesthesia techniques where possible, early surgical therapy and medical adaptation on chronic patient's therapy (in particular with regard to sedative, anticholinergic and psychotropic drugs). | Other | ASAP cohort |
Primary outcome
Postoperative complications
Time frame: 7 days
Neurological, cardiovascular, pulmonary, renal, infectious and gastrointestinal complications after surgery.
2 secondary outcomes
Days of hospitalisation
Time frame: 30 days
30-days postoperative mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Background: PubMed 31048449Borges FK, Bhandari M, Patel A, Avram V, Guerra-Farfan E, Sigamani A, Umer M, Tiboni M, Adili A, Neary J, Tandon V, Sancheti PK, Lawendy A, Jenkinson R, Ramokgopa M, Biccard BM, Szczeklik W, Wang CY, Landoni G, Forget P, Popova E, Wood G, Nabi Nur A, John B, Sleczka P, Feibel RJ, Balaguer-Castro M, Deheshi B, Winemaker M, de Beer J, Kolesar R, Teixidor-Serra J, Tomas-Hernandez J, McGillion M, Shanthanna H, Moppett I, Vincent J, Pettit S, Harvey V, Gauthier L, Alvarado K, Devereaux PJ. Rationale and design of the HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) Trial: a protocol for an international randomised controlled trial evaluating early surgery for hip fracture patients. BMJ Open. 2019 May 1;9(4):e028537. doi: 10.1136/bmjopen-2018-028537.
- Results publication: PubMed 29663067Matsuo M, Yamagami T, Higuchi A. Impact of age on postoperative complication rates among elderly patients with hip fracture: a retrospective matched study. J Anesth. 2018 Jun;32(3):452-456. doi: 10.1007/s00540-018-2494-8. Epub 2018 Apr 16.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures, run by University of Liege at 1 site in Belgium.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 10 Jan 2023. 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 Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative complications (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04771364, which also lists 2 linked publications.
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 10 Jan 2023.