Construction of the Evaluation System of Limb Blood Circulation After Fracture of Limbs in Children

Blood Circulation Disorder Clinical Trial

Official title:

Construction of the Evaluation System of Limb Blood Circulation After Fracture of Limbs in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03700216
• Other study ID #: XH-18-014
• Status: Recruiting
• Start date: October 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2018
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Ting Zhu, PhD
• Phone: +86-18101878907
• Email: zhuting[@]xinhuamed.com.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The investigator will retrospect the data of operative patients with limb fracture in Pediatric Orthopedics Unit of Shanghai Xinhua Hospital in 2016 to collect the basic information about this kind of patient, including age, gender, kind of fracture, temperature and color of skin, swell, artery pulse, laboratory test indicators, method of fixation, and the usage of mannitol. Then, combining the professionals' suggestions, the investigator will use multi-factor regression to identify the independent risk factors of blood circulation disorder. According to the independent risk factors, the early-warning model of blood circulation disorder will be built, and the rating scale as well. Finally, the critical value of blood circulation disorder after limb fracture will be set by receiver operating characteristic curve.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 201
• Est. completion date: September 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Children with nerve damage which have caused dysfunction such as sensory and motor;

• Children with fracture in other parts or organic diseases.

Related Conditions & MeSH terms

• Blood Circulation Disorder

Locations

Country	Name	City	State
China	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of adverse events	The adverse events include acute ischemic necrosis, osteofascial compartment syndrome and disability.	Within 1 year after mannitol treatment
Secondary	Blood oxygen saturation at the end of extremities	Oxygen saturation is the fraction of oxygen-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the blood, which can reflect the status of blood circulation. Blood oxygen saturation can be get by using percutaneous oxygen saturation monitor.	Within 1 year after mannitol treatment