The Research About the ACS After Femoropopliteal Arterial Injuries

Recruiting

• Conditions: Acute Compartment Syndrome
• Interventions: Procedure: fasciotomy

• Registration Number: NCT05030259
• Lead Sponsor: Hebei Medical University Third Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-25
• Last Update Submitted: 2021-08-25
• Study Start: 2021-09-01
• Study First Posted: 2021-09-01
• Last Update Posted: 2021-09-01
• Primary Completion: 2023-12-01
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with fasciotomy	fasciotomy	-

Primary Outcome Measures

Name	Time	Method
the rate of amputation	up to 6 months
fasciotomy performed or not	up to 2 weeks

Secondary Outcome Measures

Name	Time	Method
hospital lengths of stay	up to 6 months
injury mechanism of patients	up to 1 week
the costs of hospitalization	up to 2 months
the time of using tourniquet	up to 1 week
concomitant injury of patients	up to 1 week
admission lactate of patients	up to 1 month
admission International Normalized Ratio of patients	up to 1 month
the rate of primary skin closure	up to 1 months
tourniquet used or not	up to 1 week
the time to surgical intervention	up to 1 month
extremity Abbreviated Injury Scale of patients	up to 1 week	minimum is 1, maximum is 6, higher scores mean a worse outcome
Injury Severity Score of patients	up to 1 week	minimum is 0, maximum is 75, higher scores mean a worse outcome
time of skin closure	up to 1 month
admission hemoglobin of patients	up to 1 month
admission pH of patients	up to 1 month
postoperative lactate 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

Trial Locations

Locations (1)

the Third Hospital of Hebei Medical Univesity; 🇨🇳 Shijiazhuang, Hebei, China