Iliofemoral Artery InjuryNCT00900848
Posterior Tibial Artery Bypass for Iliofemoral Artery Injury Associated With Massive Blood Loss and Shock
An observational study of Iliofemoral Artery Injury and Shock, run by The Second Hospital of Qinhuangdao.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Iliofemoral Artery Injury, Shock
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Jan 2009
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 8 patients
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Iliofemoral Artery Injury, Shock
- Keywords
- Posterior tibial artery bypass, Iliofemoral artery injury, Shock, Reconstruction
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 8 | 8 patients |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iliofemoral Artery InjuryStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Qinhuangdao
- Sponsor type
- University, hospital or other
- Investigators
- Xu Zhang, MD, Study chair, The Second Hospital of Qinhuangdao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900848
- Sponsor's protocol ID
- SHQ-0905-A
- Status last verified
- May 2009
- First submitted
- 9 May 2009
- Last updated
- 13 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00900848
- Acronym / sponsor ID
- SHQ-0905-A
- Conditions
- Iliofemoral Artery Injury, Shock
- Keywords
- Posterior tibial artery bypass, Iliofemoral artery injury, Shock, Reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- The Second Hospital of QinhuangdaoUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 13 May 2009 (estimated)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 8 | – | –8 patients |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 8 patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2009.
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.
Xu Zhang, MD study chair
The Second Hospital of Qinhuangdao
Questions about this trial
What is this clinical trial studying?
An observational study of Iliofemoral Artery Injury and Shock, run by The Second Hospital of Qinhuangdao.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 13 May 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 13 May 2009.