Acute Compartment SyndromeNCT05030259
The Research About the ACS After Femoropopliteal Arterial Injuries
An observational study of Acute Compartment Syndrome, run by Hebei Medical University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Compartment Syndrome
- What is being tested?
- fasciotomy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients with femoropopliteal arterial injuries in our hospital who will be treated with vascular repair.
Who may be able to join
- patients with femoropopliteal arterial injuries
- patients older than 18 years
Who cannot join
- Patients who did not survive to discharge
- Patients with primary amputation
- patients younger than 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Third Hospital of Hebei Medical Univesity
Shijiazhuang, Hebei, 050000
Sun Changsheng, 15176139310, 15176139310@163.com
About this study
Official title: 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.
- Conditions
- Acute Compartment Syndrome
- Being tested
- fasciotomy
- Keywords
- ACS, femoropopliteal arterial injuries, fasciotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fasciotomyProcedure or surgery
To perform fasciotomy
| Study group | Role | What they receive |
|---|---|---|
| patients with fasciotomy | Not described Receives: Procedure: fasciotomy | |
| patients without fasciotomy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of amputation
Measured: up to 6 months
fasciotomy performed or not
Measured: up to 2 weeks
Secondary outcomes (26)
the rate of primary skin closure
Measured: up to 1 months
hospital lengths of stay
Measured: up to 6 months
injury mechanism of patients
Measured: up to 1 week
the costs of hospitalization
Measured: up to 2 months
tourniquet used or not
Measured: up to 1 week
the time of using tourniquet
Measured: up to 1 week
the time to surgical intervention
Measured: up to 1 month
extremity Abbreviated Injury Scale of patients
minimum is 1, maximum is 6, higher scores mean a worse outcome
Measured: up to 1 week
Injury Severity Score of patients
minimum is 0, maximum is 75, higher scores mean a worse outcome
Measured: up to 1 week
concomitant injury of patients
Measured: up to 1 week
time of skin closure
Measured: up to 1 month
admission hemoglobin of patients
Measured: up to 1 month
admission pH of patients
Measured: up to 1 month
admission lactate of patients
Measured: up to 1 month
postoperative lactate of patients
Measured: up to 1 month
admission International Normalized Ratio of patients
Measured: up to 1 month
postoperative International Normalized Ratio of patients
Measured: up to 1 month
admission CK of patients
Measured: up to 1 month
postoperative CK of patients
Measured: up to 1 month
admission LDH of patients
Measured: up to 1 month
postoperative LDH of patients
Measured: up to 1 month
Number of Participants with Lower Extremity Arteriosclerosis Obliterans
Measured: up to 1 week
vascular repair technique of patients
Measured: up to 1 week
Number of Participants with sepsis
Measured: up to 1 month
Ischemia time of patients
Measured: up to 1 week
Postoperative knee function of patients
Measured: up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Compartment SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hou Zhiyong, Doctor, Principal investigator, Hebei Medical University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030259
- Sponsor's protocol ID
- HZY005ACS
- Status last verified
- Aug 2021
- First submitted
- 3 Aug 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: acute compartment syndrome
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACS After Femoropopliteal Arterial Injuries
- ClinicalTrials.gov ID
- NCT05030259
- Acronym / sponsor ID
- HZY005ACS
- Conditions
- Acute Compartment Syndrome
- Keywords
- ACS, femoropopliteal arterial injuries, fasciotomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with fasciotomy | – | Procedure: fasciotomy |
| patients without fasciotomy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with femoropopliteal arterial injuries in our hospital who will be treated with vascular repair.
Key inclusion criteria (2 listed)
- patients with femoropopliteal arterial injuries
- patients older than 18 years
Key exclusion criteria (3 listed)
- Patients who did not survive to discharge
- Patients with primary amputation
- patients younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fasciotomyTo perform fasciotomy | Procedure or surgery | patients with fasciotomy |
Primary outcome
the rate of amputation
Time frame: up to 6 months
fasciotomy performed or not
Time frame: up to 2 weeks
26 secondary outcomes
the rate of primary skin closure
Time frame: up to 1 months
hospital lengths of stay
Time frame: up to 6 months
injury mechanism of patients
Time frame: up to 1 week
the costs of hospitalization
Time frame: up to 2 months
tourniquet used or not
Time frame: up to 1 week
the time of using tourniquet
Time frame: up to 1 week
the time to surgical intervention
Time frame: up to 1 month
extremity Abbreviated Injury Scale of patients
Time frame: up to 1 week
Injury Severity Score of patients
Time frame: up to 1 week
concomitant injury of patients
Time frame: up to 1 week
time of skin closure
Time frame: up to 1 month
admission hemoglobin of patients
Time frame: up to 1 month
admission pH of patients
Time frame: up to 1 month
admission lactate of patients
Time frame: up to 1 month
postoperative lactate of patients
Time frame: up to 1 month
admission International Normalized Ratio of patients
Time frame: up to 1 month
postoperative International Normalized Ratio of patients
Time frame: up to 1 month
admission CK of patients
Time frame: up to 1 month
postoperative CK of patients
Time frame: up to 1 month
admission LDH of patients
Time frame: up to 1 month
postoperative LDH of patients
Time frame: up to 1 month
Number of Participants with Lower Extremity Arteriosclerosis Obliterans
Time frame: up to 1 week
vascular repair technique of patients
Time frame: up to 1 week
Number of Participants with sepsis
Time frame: up to 1 month
Ischemia time of patients
Time frame: up to 1 week
Postoperative knee function of patients
Time frame: up to 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: Yes. acute compartment syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hou Zhiyong, Doctor principal investigator
Hebei Medical University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Compartment Syndrome, run by Hebei Medical University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guo Jialiang, Doctor (18203222090, drjlguo86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of amputation (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.