Biomarkers in the Diagnosis of Acute Compartment Syndrome (BioFACTS)

University Hospital, Linkoeping

Status: Enrolling

Conditions: Tibia Fracture; Acute Compartment Syndrome

Treatments: Other: Blood samples and biopsies

Study type: Observational

Funder types: Other

Identifiers

NCT04674592

BioFACTS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

250 participants in 3 patient groups

Tibial fracture

Description:

Patients with a traumatic tibial fracture and without acute compartment syndrome.

Treatment:

Other: Blood samples and biopsies

Tibial fracture complicated by acute compartment syndrome

Description:

Patients with a tibial fracture and acute compartment syndrome of fractured leg.

Treatment:

Other: Blood samples and biopsies

Acute compartment syndrome without fracture

Description:

Patients with acute compartment syndrome but without a fracture.

Treatment:

Other: Blood samples and biopsies