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Biomarkers in the Diagnosis of Acute Compartment Syndrome — BioFACTS  

Tibia Fracture Clinical Trial

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.

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04674592
Study type Observational
Source University Hospital, Linkoeping
Contact Jörg Schilcher, MD, PhD
Phone +46101030000
Email jorg.schilcher@liu.se
Status Recruiting
Phase
Start date April 5, 2018
Completion date December 2024
View Details
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