Posterior Tibial Artery Bypass for Iliofemoral Artery Injury Associated With Massive Blood Loss and Shock

Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900848
• Other study ID #: SHQ-0905-A
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: May 11, 2009
• Start date: January 2009
• Est. completion date: January 2009

Study information

• Verified date: May 2009
• Source: The Second Hospital of Qinhuangdao
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

1. bleeding can be easily control through an open wound;

2. mild shock without life threatening conditions;

3. good blood supply to the ipsilateral lower extremity;

4. low-risk emergency artery reconstruction.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Iliofemoral Artery Injury
• Shock

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Qinhuangdao