NCT05030259

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
57mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Sep 2021Dec 2030

First Submitted

Initial submission to the registry

August 3, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
7.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

2.2 years

First QC Date

August 3, 2021

Last Update Submit

August 25, 2021

Conditions

Acute Compartment Syndrome

Keywords

ACSfemoropopliteal arterial injuriesfasciotomy

Outcome Measures

Primary Outcomes (2)

  • the rate of amputation

    up to 6 months

  • fasciotomy performed or not

    up to 2 weeks

Secondary Outcomes (26)

  • the rate of primary skin closure

    up to 1 months

  • hospital lengths of stay

    up to 6 months

  • injury mechanism of patients

    up to 1 week

  • the costs of hospitalization

    up to 2 months

  • tourniquet used or not

    up to 1 week

  • +21 more secondary outcomes

Study Arms (2)

patients with fasciotomy

Procedure: fasciotomy

patients without fasciotomy

Interventions

fasciotomyPROCEDURE

To perform fasciotomy

patients with fasciotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Third Hospital of Hebei Medical Univesity

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Interventions

Fasciotomy

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Hou Zhiyong, Doctor

    Hebei Medical University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guo Jialiang, Doctor

CONTACT

18203222090drjlguo86@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2021

First Posted

September 1, 2021

Study Start

September 1, 2021

Primary Completion

December 1, 2023

Study Completion (Estimated)

December 31, 2030

Last Updated

September 1, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

acute compartment syndrome

Shared Documents
STUDY PROTOCOL
Time Frame
2 years after the experiment was conducted
Access Criteria
all authors focusing on ACS research

Locations

CN(1)