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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013978', 'term': 'Tibial Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples, muscle biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2020-12-13', 'studyFirstSubmitQcDate': '2020-12-13', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak levels of P-myoglobin and P-creatine phosphokinase', 'timeFrame': 'Up to 5 days', 'description': 'A series of blood samples will be collected with 6-hourly interval at the following time-points:\n\n* 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).\n* 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.\n\nAcute 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.'}], 'secondaryOutcomes': [{'measure': 'MicroRNA', 'timeFrame': 'Up to 5 days', 'description': 'We also collect microRNA specific for muscle damage at the same time intervals and use it as an objective measures of muscle damage.'}, {'measure': 'Histological evidence of muscle damage', 'timeFrame': 'At internal fixation and/or fasciotomy', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Compartment Syndrome', 'Tibia Fracture']}, 'referencesModule': {'references': [{'pmid': '35501102', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nBlood samples will also be collected in patients with acute compartment syndrome without tibial fractures, to serve as a positive control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Tibial fracture group\n\nInclusion Criteria:\n\n\\- Traumatic tibial fracture\n\nExclusion Criteria:\n\n* Malignancy\n* Acute myocardial infarction\n* Kidney failure (GFR ≤35 ml/min)\n* Muscle disease\n* Paraplegia/tetraplegia\n\nNon-fracture group\n\nInclusion Criteria:\n\n\\- Suspected acute compartment syndrome\n\nExclusion Criteria:\n\n* Malignancy\n* Acute myocardial infarction\n* Kidney failure (GFR ≤35 ml/min)\n* Muscle disease\n* Paraplegia/tetraplegia\n* Associated fracture\n* Acute vascular event'}, 'identificationModule': {'nctId': 'NCT04674592', 'acronym': 'BioFACTS', 'briefTitle': 'Biomarkers in the Diagnosis of Acute Compartment Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Linkoeping'}, 'officialTitle': 'Biomarkers of Rhabdomyolysis in the Diagnosis of Acute Compartment Syndrome: Study Protocol of a Prospective Multinational, Multicentre Study in Patients With Tibial Fractures.', 'orgStudyIdInfo': {'id': 'BioFACTS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tibial fracture', 'description': 'Patients with a traumatic tibial fracture and without acute compartment syndrome.', 'interventionNames': ['Other: Blood samples and biopsies']}, {'label': 'Tibial fracture complicated by acute compartment syndrome', 'description': 'Patients with a tibial fracture and acute compartment syndrome of fractured leg.', 'interventionNames': ['Other: Blood samples and biopsies']}, {'label': 'Acute compartment syndrome without fracture', 'description': 'Patients with acute compartment syndrome but without a fracture.', 'interventionNames': ['Other: Blood samples and biopsies']}], 'interventions': [{'name': 'Blood samples and biopsies', 'type': 'OTHER', 'description': 'Blood samples for analysis of biomarkers of muscle damage. Muscle biopsies for histological analysis of muscle damage.', 'armGroupLabels': ['Acute compartment syndrome without fracture', 'Tibial fracture', 'Tibial fracture complicated by acute compartment syndrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '581 85', 'city': 'Linköping', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Jörg Schilcher, MD, PhD', 'role': 'CONTACT', 'email': 'jorg.schilcher@liu.se', 'phone': '+46101030000'}], 'facility': 'University hospital of Linkoping', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'centralContacts': [{'name': 'Jörg Schilcher, MD, PhD', 'role': 'CONTACT', 'email': 'jorg.schilcher@liu.se', 'phone': '+46101030000'}, {'name': 'Abraham Nilsson, MD', 'role': 'CONTACT', 'email': 'abraham.nilsson@regionostergotland.se', 'phone': '+46101030000'}], 'overallOfficials': [{'name': 'Jörg Schilcher, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Linkoeping'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Research Council of Southeast Sweden', 'class': 'OTHER_GOV'}, {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jörg Schilcher', 'investigatorAffiliation': 'University Hospital, Linkoeping'}}}}