The Research About the ACS After Femoropopliteal Arterial Injuries

ACS After Femoropopliteal Arterial Injuries

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Compartment Syndrome
• Intervention / Treatment: Procedure: fasciotomy

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • the Third Hospital of Hebei Medical Univesity
      • Contact: Sun Changsheng; Phone Number: 15176139310; Email: 15176139310@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with fasciotomy	Procedure: fasciotomy; To perform fasciotomy
patients without fasciotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the rate of amputation	up to 6 months
fasciotomy performed or not	up to 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
the time of using tourniquet		up to 1 week
the time to surgical intervention		up to 1 month
extremity Abbreviated Injury Scale of patients	minimum is 1, maximum is 6, higher scores mean a worse outcome	up to 1 week
Injury Severity Score of patients	minimum is 0, maximum is 75, higher scores mean a worse outcome	up to 1 week
concomitant injury of patients		up to 1 week
time of skin closure		up to 1 month
admission hemoglobin of patients		up to 1 month
admission pH of patients		up to 1 month
admission lactate of patients		up to 1 month
postoperative lactate of patients		up to 1 month
admission International Normalized Ratio of patients		up to 1 month
postoperative International Normalized Ratio of patients		up to 1 month
admission CK of patients		up to 1 month
postoperative CK of patients		up to 1 month
admission LDH of patients		up to 1 month
postoperative LDH of patients		up to 1 month
Number of Participants with Lower Extremity Arteriosclerosis Obliterans		up to 1 week
vascular repair technique of patients		up to 1 week
Number of Participants with sepsis		up to 1 month
Ischemia time of patients		up to 1 week
Postoperative knee function of patients		up to 6 month

Collaborators and Investigators

• Sponsor: Hebei Medical University Third Hospital
• Investigators: Principal Investigator: Hou Zhiyong, Doctor, Hebei medical university third hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): September 1, 2021

Study Record Updates

• Last Update Posted (Actual): September 1, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: ACS; fasciotomy; femoropopliteal arterial injuries
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Musculoskeletal Diseases; Muscular Diseases; Compartment Syndromes
• Other Study ID Numbers: HZY005ACS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: acute compartment syndrome
• IPD Sharing Time Frame: 2 years after the experiment was conducted
• IPD Sharing Access Criteria: all authors focusing on ACS research
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No