Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-26 @ 10:20 AM
Study NCT ID:
NCT04674592
Status:
UNKNOWN
Last Update Posted:
2022-11-02
First Post:
2020-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in the Diagnosis of Acute Compartment Syndrome
Sponsor:
University Hospital, Linkoeping
Organization:
Study Overview
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.
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BioFACTS
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.
Blood samples will also be collected in patients with acute compartment syndrome without tibial fractures, to serve as a positive control group.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: