The Research About the ACS After Femoropopliteal Arterial Injuries

Acute Compartment Syndrome Clinical Trial

Official title:

ACS After Femoropopliteal Arterial Injuries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05030259
• Other study ID #: HZY005ACS
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: December 31, 2030

Study information

• Verified date: August 2021
• Source: Hebei Medical University Third Hospital
• Contact: Guo Jialiang, Doctor
• Phone: 18203222090
• Email: drjlguo86[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2030
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Compartment Syndrome
• Compartment Syndromes

Intervention

Procedure:
• fasciotomy
To perform fasciotomy

Locations

Country	Name	City	State
China	the Third Hospital of Hebei Medical Univesity	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of amputation		up to 6 months
Primary	fasciotomy performed or not		up to 2 weeks
Secondary	the rate of primary skin closure		up to 1 months
Secondary	hospital lengths of stay		up to 6 months
Secondary	injury mechanism of patients		up to 1 week
Secondary	the costs of hospitalization		up to 2 months
Secondary	tourniquet used or not		up to 1 week
Secondary	the time of using tourniquet		up to 1 week
Secondary	the time to surgical intervention		up to 1 month
Secondary	extremity Abbreviated Injury Scale of patients	minimum is 1, maximum is 6, higher scores mean a worse outcome	up to 1 week
Secondary	Injury Severity Score of patients	minimum is 0, maximum is 75, higher scores mean a worse outcome	up to 1 week
Secondary	concomitant injury of patients		up to 1 week
Secondary	time of skin closure		up to 1 month
Secondary	admission hemoglobin of patients		up to 1 month
Secondary	admission pH of patients		up to 1 month
Secondary	admission lactate of patients		up to 1 month
Secondary	postoperative lactate of patients		up to 1 month
Secondary	admission International Normalized Ratio of patients		up to 1 month
Secondary	postoperative International Normalized Ratio of patients		up to 1 month
Secondary	admission CK of patients		up to 1 month
Secondary	postoperative CK of patients		up to 1 month
Secondary	admission LDH of patients		up to 1 month
Secondary	postoperative LDH of patients		up to 1 month
Secondary	Number of Participants with Lower Extremity Arteriosclerosis Obliterans		up to 1 week
Secondary	vascular repair technique of patients		up to 1 week
Secondary	Number of Participants with sepsis		up to 1 month
Secondary	Ischemia time of patients		up to 1 week
Secondary	Postoperative knee function of patients		up to 6 month