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

This study has been completed.
Sponsor:
Information provided by:
The Second Hospital of Qinhuangdao
ClinicalTrials.gov Identifier:
NCT00900848
First received: May 9, 2009
Last updated: May 11, 2009
Last verified: May 2009

May 9, 2009
May 11, 2009
January 2009
January 2009   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00900848 on ClinicalTrials.gov Archive Site
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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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

8 patients

  • Iliofemoral Artery Injury
  • Shock
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8
8 patients
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
January 2009
January 2009   (final data collection date for primary outcome measure)

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.
Both
20 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00900848
SHQ-0905-A
Yes
Microsurgery, the Second hospital of Qinhuangdao
The Second Hospital of Qinhuangdao
Not Provided
Study Chair: Xu Zhang, MD The Second Hospital of Qinhuangdao
The Second Hospital of Qinhuangdao
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP