NCT04771364

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

6 years

First QC Date

February 22, 2021

Last Update Submit

January 6, 2023

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    Neurological, cardiovascular, pulmonary, renal, infectious and gastrointestinal complications after surgery.

    7 days

Secondary Outcomes (2)

  • Days of hospitalisation

    30 days

  • 30-days postoperative mortality

    30 days

Study Arms (2)

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.

Other: ASAP care's protocol

Interventions

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).

ASAP cohort

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients \>65 years old with hip fracture

You may qualify if:

  • Over 65 years old patients with hip fractures between January 1st 2017 and December 31th 2022

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Liège

Liège, 4000, Belgium

Location

Related 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.

    PMID: 31048449BACKGROUND

  • 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.

    PMID: 29663067RESULT

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesiology Departement

Study Record Dates

First Submitted

February 22, 2021

First Posted

February 25, 2021

Study Start

January 1, 2017

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

January 10, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)