ACS After Femoropopliteal Arterial Injuries
| Registry | NCT05030259 |
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 80 (Estimated) |
| Sponsor | Hebei Medical University Third Hospital (Other) |
| Conditions | Acute Compartment Syndrome |
| Interventions | fasciotomy (Procedure) |
| Dates | start 2021-09-01 (estimated), primary completion 2023-12-01 (estimated), completion 2030-12-31 (estimated), first posted 2021-09-01, last updated 2021-09-01 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Acute Compartment Syndrome All trials of fasciotomy
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| patients with fasciotomy | | Procedure: fasciotomy | |
| patients without fasciotomy | | | |
- fasciotomy (Procedure): To perform fasciotomy
+Outcome measures
Primary outcomes
- the rate of amputation [up to 6 months]
- fasciotomy performed or not [up to 2 weeks]
Secondary outcomes
- 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 [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
- 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]
+Eligibility
Sex: All, ages: 18 Years to any
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
+Locations (1)
| Facility | City | Country | Status |
|---|
| the Third Hospital of Hebei Medical Univesity | Shijiazhuang, Hebei | China | Recruiting |
+Investigators