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RecruitingNCT05030259Updated Sep 1, 2021

The Research About the ACS After Femoropopliteal Arterial Injuries

An observational study in Acute Compartment Syndrome, sponsored by Hebei Medical University Third Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-01.

Sponsored by Hebei Medical University Third Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 11 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study summary

Crural Compartment syndrome is a well-known sequela after femoropopliteal arterial injuries in the lower extremity, particularly when there has been a long period of ischemia,need for ligation of a major vein, or when there is severe associated soft tissue.There is conteoversy in the treatment.

02

Conditions studied

  • Acute Compartment Syndrome

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Keywords

  • ACS
  • femoropopliteal arterial injuries
  • fasciotomy
03

In context

Compartment Syndromes

52 studies on the registry are indexed under Compartment Syndromes; 8 are open to participants now.

This study's planned enrollment of 80 is close to the median of 85 across 20 observational studies indexed under Compartment Syndromes.

Browse Compartment Syndromes studies →

Lead sponsor

Hebei Medical University Third Hospital is the lead sponsor of 29 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The patients with femoropopliteal arterial injuries in our hospital who will be treated with vascular repair.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with femoropopliteal arterial injuries
  • patients older than 18 years

Exclusion criteria

Exclusion Criteria:

  • Patients who did not survive to discharge
  • Patients with primary amputation
  • patients younger than 18 years
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • patients with fasciotomy

    Procedure: fasciotomy

  • patients without fasciotomy

Interventions

  • Procedurefasciotomy

    To perform fasciotomy

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What researchers measure

Primary outcomes

  1. the rate of amputation

    Time frame: up to 6 months

  2. fasciotomy performed or not

    Time frame: up to 2 weeks

Secondary outcomes

  1. the rate of primary skin closure

    Time frame: up to 1 months

  2. hospital lengths of stay

    Time frame: up to 6 months

  3. injury mechanism of patients

    Time frame: up to 1 week

  4. the costs of hospitalization

    Time frame: up to 2 months

  5. tourniquet used or not

    Time frame: up to 1 week

  6. the time of using tourniquet

    Time frame: up to 1 week

  7. the time to surgical intervention

    Time frame: up to 1 month

  8. extremity Abbreviated Injury Scale of patients

    minimum is 1, maximum is 6, higher scores mean a worse outcome

    Time frame: up to 1 week

  9. Injury Severity Score of patients

    minimum is 0, maximum is 75, higher scores mean a worse outcome

    Time frame: up to 1 week

  10. concomitant injury of patients

    Time frame: up to 1 week

  11. time of skin closure

    Time frame: up to 1 month

  12. admission hemoglobin of patients

    Time frame: up to 1 month

  13. admission pH of patients

    Time frame: up to 1 month

  14. admission lactate of patients

    Time frame: up to 1 month

  15. postoperative lactate of patients

    Time frame: up to 1 month

  16. admission International Normalized Ratio of patients

    Time frame: up to 1 month

  17. postoperative International Normalized Ratio of patients

    Time frame: up to 1 month

  18. admission CK of patients

    Time frame: up to 1 month

  19. postoperative CK of patients

    Time frame: up to 1 month

  20. admission LDH of patients

    Time frame: up to 1 month

  21. postoperative LDH of patients

    Time frame: up to 1 month

  22. Number of Participants with Lower Extremity Arteriosclerosis Obliterans

    Time frame: up to 1 week

  23. vascular repair technique of patients

    Time frame: up to 1 week

  24. Number of Participants with sepsis

    Time frame: up to 1 month

  25. Ischemia time of patients

    Time frame: up to 1 week

  26. Postoperative knee function of patients

    Time frame: up to 6 month

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Study locations

1 of 1 sites recruiting
  • the Third Hospital of Hebei Medical Univesity
    Shijiazhuang, Hebei 050000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — acute compartment syndrome

Supporting information: Study protocol

Time frame: 2 years after the experiment was conducted

Access criteria: all authors focusing on ACS research

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2021; primary completion for Dec 2023, 27 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 3, 2021
First posted
Sep 1, 2021
StartEst.
Sep 1, 2021
Primary completionEst.
Dec 1, 2023
CompletionEst.
Dec 31, 2030
Last update
Sep 1, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05030259
Lead sponsor
Hebei Medical University Third Hospital
Responsible party
Sponsor
First posted
Sep 1, 2021
Start date
Sep 1, 2021 (estimated)
Primary completion
Dec 1, 2023 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Sep 1, 2021

Study contacts

Guo Jialiang, Doctor
Contact
drjlguo86@gmail.com
18203222090
Hou Zhiyong, Doctor
principal investigator · Hebei Medical University Third Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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