Biomarkers in the Diagnosis of Acute Compartment Syndrome

NCT04674592 | Unknown

• 1 other identifier: BioFACTS
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Compartment Syndrome; Tibia Fracture

Outcome Measures

Primary Outcomes (1)

• Peak levels of P-myoglobin and P-creatine phosphokinase

  A series of blood samples will be collected with 6-hourly interval at the following time-points: * Admission to hospital: P-myoglobin and P-creatine phosphokinase are collected at 6-hourly intervals for a maximum of 48 hours or until definitive surgical fixation of the fracture is performed (temporary external fixation excluded). * Surgical fracture treatment: After surgical intervention (definitive surgical fracture treatment, excluding temporary external fixation), another series of blood samples is collected with 6-hourly interval for 24 hours. Acute compartment syndrome: If suspicion of acute compartment syndrome emerges, blood samples will be collected with 6-hourly interval until fasciotomy is performed or the suspicion is written off. After fasciotomy, blood samples will be continued with 6-hourly interval for 24 hours.

  Up to 5 days

Secondary Outcomes (2)

• MicroRNA

  Up to 5 days

• Histological evidence of muscle damage

  At internal fixation and/or fasciotomy

Study Arms (3)

Tibial fracture

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

Other: Blood samples and biopsies

Tibial fracture complicated by acute compartment syndrome

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

Other: Blood samples and biopsies

Acute compartment syndrome without fracture

Patients with acute compartment syndrome but without a fracture.

Other: Blood samples and biopsies

Interventions

Blood samples and biopsies OTHER

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

Acute compartment syndrome without fracture; Tibial fracture; Tibial fracture complicated by acute compartment syndrome

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a traumatic tibial fracture with or without other concomitant fractures and patients with suspected acute compartment syndrome. The study population is sampled in a consecutive way.

You may qualify if:

• \- Traumatic tibial fracture

You may not qualify if:

• Malignancy
• Acute myocardial infarction
• Kidney failure (GFR ≤35 ml/min)
• Muscle disease
• Paraplegia/tetraplegia
• Non-fracture group
• \- Suspected acute compartment syndrome
• Malignancy
• Acute myocardial infarction
• Kidney failure (GFR ≤35 ml/min)
• Muscle disease
• Paraplegia/tetraplegia
• Associated fracture
• Acute vascular event

Sponsors & Collaborators

• University Hospital, Linkoeping: lead
• Medical Research Council of Southeast Sweden: collaborator
• Helsinki University Central Hospital: collaborator

Study Sites (1)

University hospital of Linkoping

Linköping, 581 85, Sweden

RECRUITING

Related Publications (1)

• Nilsson A, Ibounig T, Lyth J, Alkner B, von Walden F, Fornander L, Ramo L, Schmidt A, Schilcher J. BioFACTS: biomarkers of rhabdomyolysis in the diagnosis of acute compartment syndrome - protocol for a prospective multinational, multicentre study involving patients with tibial fractures. BMJ Open. 2022 May 2;12(5):e059918. doi: 10.1136/bmjopen-2021-059918.

  PMID: 35501102 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples, muscle biopsies

MeSH Terms

Conditions

Tibial Fractures

Interventions

Blood Specimen Collection; Biopsy

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical

Study Officials

• Jörg Schilcher, PhD

  University Hospital, Linkoeping

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jörg Schilcher, MD, PhD

CONTACT

+46101030000; jorg.schilcher@liu.se

Abraham Nilsson, MD

CONTACT

+46101030000; abraham.nilsson@regionostergotland.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 19, 2020
• Study Start: April 5, 2018
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2024
• Last Updated: November 2, 2022

Record last verified: 2022-10

Locations

SE (1)