Biomarkers in the Diagnosis of Acute Compartment Syndrome
- Conditions
- Tibia FractureAcute Compartment Syndrome
- Interventions
- Other: Blood samples and biopsies
- Registration Number
- NCT04674592
- Lead Sponsor
- University Hospital, Linkoeping
- 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- Traumatic tibial fracture
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tibial fracture complicated by acute compartment syndrome Blood samples and biopsies Patients with a tibial fracture and acute compartment syndrome of fractured leg. Acute compartment syndrome without fracture Blood samples and biopsies Patients with acute compartment syndrome but without a fracture. Tibial fracture Blood samples and biopsies Patients with a traumatic tibial fracture and without acute compartment syndrome.
- Primary Outcome Measures
Name Time Method Peak levels of P-myoglobin and P-creatine phosphokinase Up to 5 days 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.
- Secondary Outcome Measures
Name Time Method Histological evidence of muscle damage At internal fixation and/or fasciotomy 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.
MicroRNA Up to 5 days We also collect microRNA specific for muscle damage at the same time intervals and use it as an objective measures of muscle damage.
Trial Locations
- Locations (1)
University hospital of Linkoping
🇸🇪Linkoping, Sweden