- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00900848
Posterior Tibial Artery Bypass for Iliofemoral Artery Injury Associated With Massive Blood Loss and Shock
Traumatic Disruption of Iliofemoral Arterial Segment is Often Associated With Multiple Injuries, Massive Hemorrhage, State of Shock, and Loss of Blood Supply to the Ipsilateral Lower Extremity, as Well as With High Mortality
Traumatic disruption of iliofemoral arterial segment is often associated with multiple injuries, massive hemorrhage, state of shock, and loss of blood supply to the ipsilateral lower extremity, as well as with high mortality.
The investigators describe a bypass technique. It can provide adequate blood supply to the lower extremity of the injury side. Due to a minimum amount of additional blood loss, it is a low risk procedure for salvage of the extremity and even patient's life.
Study Overview
Status
Conditions
Detailed Description
Patients were selected on the basis of the following: (1) closed injuries to the lower abdomen and/or pelvis; (2) serious hemorrhagic shock; (3) loss of blood supply to the ipsilateral lower extremity; (4) high-risk emergency artery reconstruction.
The instruments used to measure sensibility of the foot were the Semmes-Weinstein (SW) monofilament test 24 and the static two-point discrimination (2PD) test 25. The weight-bearing area of the first metatarsal head and the dorsum of the first metatarsal head were assessed. Active range of motion (ROM) of the hip, knee, and ankle joints was measured with a goniometer. The muscle strength was test using Medical Research Council (MRC) Scale. The cold intolerance of the leg was measured using the self-administered Cold Intolerance Severity Score (CISS) questionnaire 26. The maximum score is 100 and is grouped into 4 ranges (0-25, 26-50, 51-75, and 76-100) corresponding to mild, moderate, severe, and extreme severity, respectively.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- closed injuries to the lower abdomen and/or pelvis;
- serious hemorrhagic shock;
- loss of blood supply to the ipsilateral lower extremity;
- high-risk emergency artery reconstruction.
Exclusion Criteria:
- bleeding can be easily control through an open wound;
- mild shock without life threatening conditions;
- good blood supply to the ipsilateral lower extremity;
- low-risk emergency artery reconstruction.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
8
8 patients
|
Collaborators and Investigators
Investigators
- Study Chair: Xu Zhang, MD, The Second Hospital of Qinhuangdao
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHQ-0905-A
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