Biomarkers in the Diagnosis of Acute Compartment Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-05

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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

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Acute Compartment Syndrome Tibia Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tibial fracture

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

Blood samples and biopsies

Intervention Type OTHER

Blood samples for analysis of biomarkers of muscle damage. Muscle biopsies for histological analysis of muscle damage.

Tibial fracture complicated by acute compartment syndrome

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

Blood samples and biopsies

Intervention Type OTHER

Blood samples for analysis of biomarkers of muscle damage. Muscle biopsies for histological analysis of muscle damage.

Acute compartment syndrome without fracture

Patients with acute compartment syndrome but without a fracture.

Blood samples and biopsies

Intervention Type OTHER

Blood samples for analysis of biomarkers of muscle damage. Muscle biopsies for histological analysis of muscle damage.

Interventions

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Blood samples and biopsies

Blood samples for analysis of biomarkers of muscle damage. Muscle biopsies for histological analysis of muscle damage.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- Traumatic tibial fracture

\- Suspected acute compartment syndrome

Exclusion Criteria

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

Non-fracture group

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

Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No