Blood Circulation DisorderNCT03700216
Construction of the Evaluation System of Limb Blood Circulation After Fracture of Limbs in Children
An observational study of Blood Circulation Disorder, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Blood Circulation Disorder
- How many people
- 201 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with limb fractures diagnosed by X-ray film
Who may be able to join
- 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.
Who cannot join
- Children with nerve damage which have caused dysfunction such as sensory and motor;
- Children with fracture in other parts or organic diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Ting Zhu, PhD, +86-18101878907, zhuting@xinhuamed.com.cn
About this study
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.
Read the detailed 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.
- Conditions
- Blood Circulation Disorder
- Keywords
- limb Fracture, limb blood circulation, early-warning model, Children
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Limb Blood circulation disorder
Number of participants with circulatory disorders (using mannitol treatment) after limb fracture
Measured: Within 1 year after mannitol treatment
Secondary outcomes (2)
Number of adverse events
The adverse events include acute ischemic necrosis, osteofascial compartment syndrome and disability.
Measured: Within 1 year after mannitol treatment
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.
Measured: Within 1 year after mannitol treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start1 Oct 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Circulation DisorderStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ting Zhu, PhD, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03700216
- Sponsor's protocol ID
- XH-18-014
- Status last verified
- Oct 2018
- First submitted
- 26 Sep 2018
- Last updated
- 19 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of the Evaluation System of Limb Blood Circulation After Fracture of Limbs in Children
- ClinicalTrials.gov ID
- NCT03700216
- Acronym / sponsor ID
- XH-18-014
- Conditions
- Blood Circulation Disorder
- Keywords
- limb Fracture, limb blood circulation, early-warning model, Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with limb fractures diagnosed by X-ray film
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Children with nerve damage which have caused dysfunction such as sensory and motor;
- Children with fracture in other parts or organic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with Limb Blood circulation disorder
Time frame: Within 1 year after mannitol treatment
Number of participants with circulatory disorders (using mannitol treatment) after limb fracture
2 secondary outcomes
Number of adverse events
Time frame: Within 1 year after mannitol treatment
Blood oxygen saturation at the end of extremities
Time frame: Within 1 year after mannitol treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting Zhu, PhD principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Circulation Disorder, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Zhu, PhD (+86-18101878907, zhuting@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Limb Blood circulation disorder (time frame: Within 1 year after mannitol treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.