NCT03700216

Brief Summary

This study is aimed to construct a multi-parameter early-warning model based on usage of mannitol, using multi-factor regression and combining with previous clinical experience, literature, expert opinions. The investigators will evaluate the predictive value of the model for mannitol usage and gypsum cutting open through cohort study verification.

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
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

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

September 26, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

October 19, 2018

Status Verified

October 1, 2018

Enrollment Period

1.2 years

First QC Date

September 26, 2018

Last Update Submit

October 17, 2018

Conditions

Blood Circulation Disorder

Keywords

limb Fracturelimb blood circulationearly-warning modelChildren

Outcome Measures

Primary Outcomes (1)

  • Number of participants with Limb Blood circulation disorder

    Number of participants with circulatory disorders (using mannitol treatment) after limb fracture

    Within 1 year after mannitol treatment

Secondary Outcomes (2)

  • Number of adverse events

    Within 1 year after mannitol treatment

  • Blood oxygen saturation at the end of extremities

    Within 1 year after mannitol treatment

Eligibility Criteria

AgeUp to 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children with limb fractures diagnosed by X-ray film

You may qualify if:

  • Age from 0 to 14 years;
  • Children with limb fractures diagnosed by X-ray film;
  • The surgical method is open reduction and wire-pin fixation or steel plate internal fixation;
  • Children with postoperative plaster fixation;
  • Children whose guardian signed informed written consent.

You may not qualify if:

  • Children with nerve damage which have caused dysfunction such as sensory and motor;
  • Children with fracture in other parts or organic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Study Officials

  • Ting Zhu, PhD

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Zhu, PhD

CONTACT

+86-18101878907zhuting@xinhuamed.com.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2018

First Posted

October 9, 2018

Study Start

October 1, 2018

Primary Completion

December 31, 2019

Study Completion

September 30, 2020

Last Updated

October 19, 2018

Record last verified: 2018-10

Locations

CN(1)