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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00900848
First Posted: May 13, 2009
Last Update Posted: May 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Second Hospital of Qinhuangdao
  Purpose

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.


Condition
Iliofemoral Artery Injury Shock

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by The Second Hospital of Qinhuangdao:

Enrollment: 8
Study Start Date: January 2009
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
8
8 patients

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
8 patients
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900848


Sponsors and Collaborators
The Second Hospital of Qinhuangdao
Investigators
Study Chair: Xu Zhang, MD The Second Hospital of Qinhuangdao
  More Information

Responsible Party: Microsurgery, the Second hospital of Qinhuangdao
ClinicalTrials.gov Identifier: NCT00900848     History of Changes
Other Study ID Numbers: SHQ-0905-A
First Submitted: May 9, 2009
First Posted: May 13, 2009
Last Update Posted: May 13, 2009
Last Verified: May 2009

Keywords provided by The Second Hospital of Qinhuangdao:
Posterior tibial artery bypass
Iliofemoral artery injury
Shock
Reconstruction

Additional relevant MeSH terms:
Wounds and Injuries
Shock
Pathologic Processes