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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04771364
Other study ID # ASAP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date December 31, 2022

Study information

Verified date January 2023
Source University of Liege
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 800
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Over 65 years old patients with hip fractures between January 1st 2017 and December 31th 2022 Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ASAP care's protocol
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).

Locations

Country Name City State
Belgium CHU de Liège Liège

Sponsors (1)

Lead Sponsor Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View Citation

Matsuo 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative complications Neurological, cardiovascular, pulmonary, renal, infectious and gastrointestinal complications after surgery. 7 days
Secondary Days of hospitalisation Total hospitalisation days 30 days
Secondary 30-days postoperative mortality Mortality 1 month after surgery 30 days
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