Clinical trial NCT04674592: Biomarkers in the Diagnosis of Acute Compartment Syndrome
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Compartment Syndrome
Tibia Fracture
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
Collaborators: name: Medical Research Council of Southeast Sweden
name: Helsinki University Central Hospital
First posted: 2020-12-19
Enrollment: 250
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Tibial fracture group

Inclusion Criteria:

- Traumatic tibial fracture

Exclusion Criteria:

* Malignancy
* Acute myocardial infarction
* Kidney failure (GFR ≤35 ml/min)
* Muscle disease
* Paraplegia/tetraplegia

Non-fracture group

Inclusion Criteria:

- Suspected acute compartment syndrome

Exclusion Criteria:

* Malignancy
* Acute myocardial infarction
* Kidney failure (GFR ≤35 ml/min)
* Muscle disease
* Paraplegia/tetraplegia
* Associated fracture
* Acute vascular event

Primary outcomes:
measure: Peak levels of P-myoglobin and P-creatine phosphokinase
timeFrame: Up to 5 days
Secondary outcomes:
measure: MicroRNA
timeFrame: Up to 5 days
measure: Histological evidence of muscle damage
timeFrame: At internal fixation and/or fasciotomy
Other outcomes:
Locations:
city: Linkoping
country: Sweden
facility: University hospital of Linkoping
Study officials:
affiliation: University Hospital, Linkoeping
name: Jörg Schilcher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.