NCT04674592

Biomarkers in the Diagnosis of Acute Compartment Syndrome

Biomarkers of Rhabdomyolysis in the Diagnosis of Acute Compartment Syndrome: Study Protocol of a Prospective Multinational, Multicentre Study in Patients With Tibial Fractures.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: University Hospital, Linkoeping · Academic / Other
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Compartment Syndrome
• Tibia Fracture

Interventions

Type	Name	Description
OTHER	Blood samples and biopsies	Blood samples for analysis of biomarkers of muscle damage. Muscle biopsies for histological analysis of muscle damage.

Timeline

• Start date: 2018-04-05
• Primary completion: 2023-06-01
• Completion: 2024-12-01
• First posted: 2020-12-19
• Last updated: 2022-11-02

Locations

1 site across 1 country: Sweden