NCT03429010

Brief Summary

This study is going to research the hypothesis that to strengthen the comprehensive treatment of perioperative anesthesia is possible to improve the prognosis of patients with hip fracture and reduce mortality. This is a randomized controlled pilot study aimed to elderly patients with hip fracture on one side and needing surgical treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

January 18, 2018

Last Update Submit

September 23, 2019

Conditions

AnesthesiaHip Fracture SurgeryNursing

Keywords

AnesthesiaHip Fracture

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Mortality in 6 months of postoperative

    6 months after surgery

Secondary Outcomes (9)

  • Visual Analogue Score(VAS)

    within two days after surgery

  • Complications

    post-operation to discharge, an average of 2 weeks

  • Death rate

    Within 30 days and 1 year after surgery

  • Survival time

    up to one year after surgery

  • Compliance score

    Duration of hospital stay, an average of 2 weeks

  • +4 more secondary outcomes

Study Arms (2)

New "guideline"

EXPERIMENTAL

New "guideline" anesthesia strategy team (Group A)

Procedure: New "guideline" anesthesia strategy team

Current strategy

NO INTERVENTION

Current anesthesia strategy team (Group B)

Interventions

New "guideline" anesthesia strategy teamPROCEDURE

New "guideline" anesthesia strategy team

New "guideline"

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients ≥ 75 years old;
  • Patients with hip fracture purely and surgical treatment is scheduled.

You may not qualify if:

  • Surgical treatment has been performed after entering hospital;
  • Multiple trauma: multiple fractures; chest, abdomen, pelvis and sacral trauma; severe head injury, etc.
  • Refuse to sign informed consent;
  • Investigator thinks he/she is inappropriate to carry out this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 32500, China

RECRUITING

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2018

First Posted

February 12, 2018

Study Start

July 1, 2018

Primary Completion

November 1, 2019

Study Completion

December 31, 2020

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations

CN(1)