Acute Compartment SyndromeBioFACTSNCT04674592
Biomarkers in the Diagnosis of Acute Compartment Syndrome
An observational study of Acute Compartment Syndrome and Tibia Fracture, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
This prospective multinational, multicentre cohort study aims to investigate the hypothesis that biomarkers of muscle cell damage can predict acute compartment syndrome in patients with tibial fractures. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Acute Compartment Syndrome, Tibia Fracture
- What is being tested?
- Blood samples and biopsies
- How many people
- 250 participants
- Where
- 1 siteSweden
- Study dates
- 5 Apr 2018to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a traumatic tibial fracture with or without other concomitant fractures and patients with suspected acute compartment syndrome. The study population is sampled in a consecutive way.
Who may be able to join
- Traumatic tibial fracture
- Suspected acute compartment syndrome
Who cannot join
- Malignancy
- Acute myocardial infarction
- Kidney failure (GFR ≤35 ml/min)
- Muscle disease
- Paraplegia/tetraplegia
- Non-fracture group
Show all 13Show fewer
- Malignancy
- Acute myocardial infarction
- Kidney failure (GFR ≤35 ml/min)
- Muscle disease
- Paraplegia/tetraplegia
- Associated fracture
- Acute vascular event
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
University hospital of Linkoping
Linköping, 581 85
Jörg Schilcher, MD, PhD, +46101030000, jorg.schilcher@liu.se
About this study
Official title: Biomarkers of Rhabdomyolysis in the Diagnosis of Acute Compartment Syndrome: Study Protocol of a Prospective Multinational, Multicentre Study in Patients With Tibial Fractures.
This prospective multinational, multicentre cohort study aims to investigate the hypothesis that biomarkers of muscle cell damage can predict acute compartment syndrome in patients with tibial fractures.
Read the detailed description
Patients with a tibial fracture are included. P-myoglobin and P-creatine phosphokinase are analysed at 6-hourly intervals pre- and if applicable, postoperatively after surgical fixation or fasciotomy. Also, blood samples will be collected in 6 hourly intervals if acute compartment syndrome is suspected. An expert panel of senior orthopaedic surgeons will retrospectively assess study data and classify patients who had undergone fasciotomy into those with and without acute compartment syndrome.
Blood samples will also be collected in patients with acute compartment syndrome without tibial fractures, to serve as a positive control group.
- Conditions
- Acute Compartment Syndrome, Tibia Fracture
- Being tested
- Blood samples and biopsies
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples and biopsiesOther
Blood samples for analysis of biomarkers of muscle damage. Muscle biopsies for histological analysis of muscle damage.
| Study group | Role | What they receive |
|---|---|---|
| Tibial fracture | Patients with a traumatic tibial fracture and without acute compartment syndrome. Receives: Other: Blood samples and biopsies | |
| Tibial fracture complicated by acute compartment syndrome | Patients with a tibial fracture and acute compartment syndrome of fractured leg. Receives: Other: Blood samples and biopsies | |
| Acute compartment syndrome without fracture | Patients with acute compartment syndrome but without a fracture. Receives: Other: Blood samples and biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak levels of P-myoglobin and P-creatine phosphokinase
A series of blood samples will be collected with 6-hourly interval at the following time-points:
- Admission to hospital: P-myoglobin and P-creatine phosphokinase are collected at 6-hourly intervals for a maximum of 48 hours or until definitive surgical fixation of the fracture is performed (temporary external fixation excluded).
- Surgical fracture treatment: After surgical intervention (definitive surgical fracture treatment, excluding temporary external fixation), another series of blood samples is collected with 6-hourly interval for 24 hours.
Acute compartment syndrome: If suspicion of acute compartment syndrome emerges, blood samples will be collected with 6-hourly interval until fasciotomy is performed or the suspicion is written off. After fasciotomy, blood samples will be continued with 6-hourly interval for 24 hours.
Measured: Up to 5 days
Secondary outcomes (2)
MicroRNA
We also collect microRNA specific for muscle damage at the same time intervals and use it as an objective measures of muscle damage.
Measured: Up to 5 days
Histological evidence of muscle damage
At surgery (internal fixation or fasciotomy) biopsies are taken from tibialis anterior muscle in some centres for further histological analysis. Two biopsies are taken from the fractured leg, one near the fracture and one at distance, and one biopsy from the uninjured leg (control). Biopsies are frozen within 30 minutes using liquid nitrogen and isopentane and stored in minus 80 degrees Celsius.
Measured: At internal fixation and/or fasciotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start5 Apr 2018
- Primary completionJun 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council of Southeast Sweden, Helsinki University Central Hospital
- Responsible party
- Principal investigator, Jörg Schilcher, University Hospital, Linkoeping
- Investigators
- Jörg Schilcher, PhD, Principal investigator, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674592
- Sponsor's protocol ID
- BioFACTS
- Acronym
- BioFACTS
- Status last verified
- Oct 2022
- First submitted
- 13 Dec 2020
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nilsson A, Ibounig T, Lyth J, Alkner B, von Walden F, Fornander L, Ramo L, Schmidt A, Schilcher J. BioFACTS: biomarkers of rhabdomyolysis in the diagnosis of acute compartment syndrome - protocol for a prospective multinational, multicentre study involving patients with tibial fractures. BMJ Open. 2022 May 2;12(5):e059918. doi: 10.1136/bmjopen-2021-059918.
PubMed 35501102
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Rhabdomyolysis in the Diagnosis of Acute Compartment Syndrome: Study Protocol of a Prospective Multinational, Multicentre Study in Patients With Tibial Fractures.
- ClinicalTrials.gov ID
- NCT04674592
- Acronym / sponsor ID
- BioFACTS / BioFACTS
- Conditions
- Acute Compartment Syndrome, Tibia Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Medical Research Council of Southeast Sweden, Helsinki University Central Hospital
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Dec 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.
This prospective multinational, multicentre cohort study aims to investigate the hypothesis that biomarkers of muscle cell damage can predict acute compartment syndrome in patients with tibial fractures.
Detailed description
Patients with a tibial fracture are included. P-myoglobin and P-creatine phosphokinase are analysed at 6-hourly intervals pre- and if applicable, postoperatively after surgical fixation or fasciotomy. Also, blood samples will be collected in 6 hourly intervals if acute compartment syndrome is suspected. An expert panel of senior orthopaedic surgeons will retrospectively assess study data and classify patients who had undergone fasciotomy into those with and without acute compartment syndrome.
Blood samples will also be collected in patients with acute compartment syndrome without tibial fractures, to serve as a positive control group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tibial fracture | – | Other: Blood samples and biopsiesPatients with a traumatic tibial fracture and without acute compartment syndrome. |
| Tibial fracture complicated by acute compartment syndrome | – | Other: Blood samples and biopsiesPatients with a tibial fracture and acute compartment syndrome of fractured leg. |
| Acute compartment syndrome without fracture | – | Other: Blood samples and biopsiesPatients with acute compartment syndrome but without a fracture. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a traumatic tibial fracture with or without other concomitant fractures and patients with suspected acute compartment syndrome. The study population is sampled in a consecutive way.
Key inclusion criteria (2 listed)
- Traumatic tibial fracture
- Suspected acute compartment syndrome
Key exclusion criteria (13 listed)
- Malignancy
- Acute myocardial infarction
- Kidney failure (GFR ≤35 ml/min)
- Muscle disease
- Paraplegia/tetraplegia
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 |
|---|---|---|
| Blood samples and biopsiesBlood samples for analysis of biomarkers of muscle damage. Muscle biopsies for histological analysis of muscle damage. | Other | Acute compartment syndrome without fracture, Tibial fracture, Tibial fracture complicated by acute compartment syndrome |
Primary outcome
Peak levels of P-myoglobin and P-creatine phosphokinase
Time frame: Up to 5 days
A series of blood samples will be collected with 6-hourly interval at the following time-points: * Admission to hospital: P-myoglobin and P-creatine phosphokinase are collected at 6-hourly intervals for a maximum of 48 hours or until definitive surgical fixation of the fracture is performed (temporary external fixation excluded). * Surgical fracture treatment: After surgical intervention (definitive surgical fracture treatment, excluding temporary external fixation), another series of blood samples is collected with 6-hourly interval for 24 hours. Acute compartment syndrome: If suspicion of acute compartment syndrome emerges, blood samples will be collected with 6-hourly interval until fasciotomy is performed or the suspicion is written off. After fasciotomy, blood samples will be continued with 6-hourly interval for 24 hours.
2 secondary outcomes
MicroRNA
Time frame: Up to 5 days
Histological evidence of muscle damage
Time frame: At internal fixation and/or fasciotomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Derived from this study: PubMed 35501102Nilsson A, Ibounig T, Lyth J, Alkner B, von Walden F, Fornander L, Ramo L, Schmidt A, Schilcher J. BioFACTS: biomarkers of rhabdomyolysis in the diagnosis of acute compartment syndrome - protocol for a prospective multinational, multicentre study involving patients with tibial fractures. BMJ Open. 2022 May 2;12(5):e059918. doi: 10.1136/bmjopen-2021-059918.
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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. This study is not recruiting at the moment.
Jörg Schilcher, PhD principal investigator
University Hospital, Linkoeping
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 and Tibia Fracture, run by University Hospital, Linkoeping at 1 site in Sweden.
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 13 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. 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 Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jörg Schilcher, MD, PhD (+46101030000, jorg.schilcher@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak levels of P-myoglobin and P-creatine phosphokinase (time frame: Up to 5 days). 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 NCT04674592, which also lists 1 linked publication.
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 2 Nov 2022.