Acute Compartment SyndromeNCT04529330
The Research About Acute Compartment Syndrome
An observational study of Acute Compartment Syndrome, run by Hebei Medical University Third Hospital at 1 site in China.
Trial summary
Acute compartment syndrome (ACS) is defined as a clinical entity originated from trauma or other conditions, and remains challenging to diagnose and treat effectively. Threre is the controversy in diagnosing, treating ACS. It was found that there was no criterion about the ACS, and result unnecessary osteotomy. 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 Jan 2019to 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
- Adult, Older adult
Study population: The severe tibial plateau (Ⅴand Ⅵ according to Schatzker's classification) in our hospital who will be treated with open internal fixation in our hospital
Who may be able to join
- Fracture patients with Schatzker V and VI,
- Who were older than eighteen years.
Who cannot join
- The exclusion criteria were pathologic, extra-articular proximal tibial fracture,
- Patients who was eighteen years or younger.
- Patients treated with other implant,
- underwent conservative management were also excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ma Lijie, Doctor contact
China1 site, 1 recruiting
- Recruiting
the Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Chen Wei
About this study
Official title: Acute Compartment Syndrome
Acute compartment syndrome (ACS) is defined as a clinical entity originated from trauma or other conditions, and remains challenging to diagnose and treat effectively. Threre is the controversy in diagnosing, treating ACS. It was found that there was no criterion about the ACS, and result unnecessary osteotomy. The presence of clinical assessment (5P) always means the necrosis of muscles and was the most serious or irreversible stage of ACS. Besides pressure methods, the threshold of pressure identifying ACS was also controversial.
- Conditions
- Acute Compartment Syndrome
- Being tested
- fasciotomy
- Keywords
- ACS, Tibial plateau fractures, Tibial shaft fractures
- Medical subject headings
- Tibial Plateau Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fasciotomyProcedure or surgery
if it was suspected with ACS, the fasciotomy was conducted. but if the blister observed, it means decreased conmpartment sydrome. therefore, the blister observed can avoid unnecessary fasciotomy to patients suspected with ACS
| Study group | Role | What they receive |
|---|---|---|
| fractures with blister appeared | tibial plateau fractures with blister observed Receives: Procedure: fasciotomy | |
| fractures without blister appeared | tibial plateau fractures without blister observed Receives: Procedure: fasciotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
injury mechanism
The relative data was collected about injury mechanism such as high falling accident, traffic accident, fall from standing height,Crushing
Measured: up to 1 weeks
the time when the blister appeared
The relative data was collected about the time when the blister appeared after injury
Measured: up to 4 weeks
time to reconstructive surgery
The relative data was collected about time to reconstructive surgery
Measured: time to when the surgery was conducted after 2 weeks
union time
The relative data was collected about union time
Measured: through study completion, an average of 1 year
No non-anatomic gap or step (larger than 5 mm)
The relative data was collected about complications
Measured: through study completion, an average of 1 year
secondary loss of reduction
The relative data was collected about complications
Measured: through study completion, an average of 1 year
Deep venous thrombosis
The relative data was collected about complications
Measured: through study completion, an average of 1 year
superficial wound problems
The relative data was collected about complications
Measured: through study completion, an average of 1 year
blister skin immunochemistry and immunofluorescence analysis
CK1, 5, 10, claudin 1, 2 and occludin as determined by immunochemistry analysis, and skin barrier proteins; claudin 1, 2 and occludin was determined by immunofluorescence analysis and qPCR.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
CK levels
CK levels
Measured: through hospitalization completion, an average of 1 month
chloride levels
chloride levels
Measured: through hospitalization completion, an average of 1 month
UREA levels
UREA levels
Measured: through hospitalization completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Jan 2019
- Primary completion9 Sep 2022 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Case-control
- 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
- NCT04529330
- Sponsor's protocol ID
- HZY001ACS
- Status last verified
- Jul 2021
- First submitted
- 19 Aug 2020
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: acute compartment syndrome
Publications
Guo J, Yin Y, Jin L, Zhang R, Hou Z, Zhang Y. Acute compartment syndrome: Cause, diagnosis, and new viewpoint. Medicine (Baltimore). 2019 Jul;98(27):e16260. doi: 10.1097/MD.0000000000016260.
PubMed 31277147Wang T, Yang S, Guo J, Long Y, Hou Z. Predictors of muscle necrosis in patients with acute compartment syndrome. Int Orthop. 2023 Apr;47(4):905-913. doi: 10.1007/s00264-023-05699-9. Epub 2023 Jan 30.
PubMed 36715712
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Compartment Syndrome
- ClinicalTrials.gov ID
- NCT04529330
- Acronym / sponsor ID
- HZY001ACS
- Conditions
- Acute Compartment Syndrome
- Keywords
- ACS, Tibial plateau fractures, Tibial shaft fractures
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 9 Sep 2022 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 27 Aug 2020 (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.
Acute compartment syndrome (ACS) is defined as a clinical entity originated from trauma or other conditions, and remains challenging to diagnose and treat effectively. Threre is the controversy in diagnosing, treating ACS. It was found that there was no criterion about the ACS, and result unnecessary osteotomy. The presence of clinical assessment (5P) always means the necrosis of muscles and was the most serious or irreversible stage of ACS. Besides pressure methods, the threshold of pressure identifying ACS was also controversial.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fractures with blister appeared | – | Procedure: fasciotomytibial plateau fractures with blister observed |
| fractures without blister appeared | – | Procedure: fasciotomytibial plateau fractures without blister observed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The severe tibial plateau (Ⅴand Ⅵ according to Schatzker's classification) in our hospital who will be treated with open internal fixation in our hospital
Key inclusion criteria (2 listed)
- Fracture patients with Schatzker V and VI,
- Who were older than eighteen years.
Key exclusion criteria (4 listed)
- The exclusion criteria were pathologic, extra-articular proximal tibial fracture,
- Patients who was eighteen years or younger.
- Patients treated with other implant,
- underwent conservative management were also excluded.
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 |
|---|---|---|
| fasciotomyif it was suspected with ACS, the fasciotomy was conducted. but if the blister observed, it means decreased conmpartment sydrome. therefore, the blister observed can avoid unnecessary fasciotomy to patients suspected with ACS | Procedure or surgery | fractures with blister appeared, fractures without blister appeared |
Primary outcome
injury mechanism
Time frame: up to 1 weeks
The relative data was collected about injury mechanism such as high falling accident, traffic accident, fall from standing height,Crushing
the time when the blister appeared
Time frame: up to 4 weeks
The relative data was collected about the time when the blister appeared after injury
time to reconstructive surgery
Time frame: time to when the surgery was conducted after 2 weeks
The relative data was collected about time to reconstructive surgery
union time
Time frame: through study completion, an average of 1 year
The relative data was collected about union time
No non-anatomic gap or step (larger than 5 mm)
Time frame: through study completion, an average of 1 year
The relative data was collected about complications
secondary loss of reduction
Time frame: through study completion, an average of 1 year
The relative data was collected about complications
Deep venous thrombosis
Time frame: through study completion, an average of 1 year
The relative data was collected about complications
superficial wound problems
Time frame: through study completion, an average of 1 year
The relative data was collected about complications
blister skin immunochemistry and immunofluorescence analysis
Time frame: through study completion, an average of 1 year
CK1, 5, 10, claudin 1, 2 and occludin as determined by immunochemistry analysis, and skin barrier proteins; claudin 1, 2 and occludin was determined by immunofluorescence analysis and qPCR.
3 secondary outcomes
CK levels
Time frame: through hospitalization completion, an average of 1 month
chloride levels
Time frame: through hospitalization completion, an average of 1 month
UREA levels
Time frame: through hospitalization completion, an average of 1 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 4 Aug 2021.
- Background: PubMed 31277147Guo J, Yin Y, Jin L, Zhang R, Hou Z, Zhang Y. Acute compartment syndrome: Cause, diagnosis, and new viewpoint. Medicine (Baltimore). 2019 Jul;98(27):e16260. doi: 10.1097/MD.0000000000016260.
- Derived from this study: PubMed 36715712Wang T, Yang S, Guo J, Long Y, Hou Z. Predictors of muscle necrosis in patients with acute compartment syndrome. Int Orthop. 2023 Apr;47(4):905-913. doi: 10.1007/s00264-023-05699-9. Epub 2023 Jan 30.
- Individual participant dataSharing planned: Yes. acute compartment syndrome
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Compartment Syndromes
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.
Ma Lijie, Doctor contact
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 4 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 4 Aug 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?
injury mechanism (time frame: up to 1 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04529330, which also lists 2 linked publications.
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 4 Aug 2021.