Biomarkers in the Diagnosis of Acute Compartment Syndrome

Last updated: October 31, 2022
Sponsor: University Hospital, Linkoeping
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04674592
BioFACTS
  • Ages 15-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Tibial fracture group Inclusion Criteria:

  • Traumatic tibial fracture

Exclusion

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

Study Design

Total Participants: 250
Study Start date:
April 05, 2018
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • University hospital of Linkoping

    Linkoping, 581 85
    Sweden

    Active - Recruiting

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