Biomarkers in the Diagnosis of Acute Compartment Syndrome

Tibia Fracture Clinical Trial

— BioFACTS  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT04674592
• Other study ID #: BioFACTS
• Status: Recruiting
• Start date: April 5, 2018
• Est. completion date: December 2024

Study information

• Verified date: October 2022
• Source: University Hospital, Linkoeping
• Contact: Jörg Schilcher, MD, PhD
• Phone: +46101030000
• Email: jorg.schilcher[@]liu.se
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2024
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

Tibial fracture group

Inclusion Criteria:

• Traumatic tibial fracture

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

Related Conditions & MeSH terms

• Acute Compartment Syndrome
• Compartment Syndromes
• Syndrome
• Tibia Fracture
• Tibial Fractures

Intervention

Other:
• Blood samples and biopsies
Blood samples for analysis of biomarkers of muscle damage. Muscle biopsies for histological analysis of muscle damage.

Locations

Country	Name	City	State
Sweden	University hospital of Linkoping	Linkoping

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Linkoeping	Helsinki University Central Hospital, Medical Research Council of Southeast Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MicroRNA	We also collect microRNA specific for muscle damage at the same time intervals and use it as an objective measures of muscle damage.	Up to 5 days
Secondary	Histological evidence of muscle damage	At surgery (internal fixation or fasciotomy) biopsies are taken from tibialis anterior muscle in some centres for further histological analysis. Two biopsies are taken from the fractured leg, one near the fracture and one at distance, and one biopsy from the uninjured leg (control). Biopsies are frozen within 30 minutes using liquid nitrogen and isopentane and stored in minus 80 degrees Celsius.	At internal fixation and/or fasciotomy