Prevention of Postoperative Bleeding in Subcapital Femoral Fractures
NCT ID: NCT02150720
Last Updated: 2016-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
161 participants
INTERVENTIONAL
2013-02-28
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tranexamic acid
Tranexamic acid, 1g intra-articular before closing the surgery wound
Tranexamic Acid
1g intra-articular before closing the wound surgery
Electrocauterization
Coagulation blood from vessels by means of a electrocautery.
Fibrin glue
One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery,
Fibrin glue
5mL intra-articular before closing the wound surgery
Electrocauterization
Coagulation blood from vessels by means of a electrocautery.
Usual hemostasia
Electrocauterization
Electrocauterization
Coagulation blood from vessels by means of a electrocautery.
Interventions
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Tranexamic Acid
1g intra-articular before closing the wound surgery
Fibrin glue
5mL intra-articular before closing the wound surgery
Electrocauterization
Coagulation blood from vessels by means of a electrocautery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with unilateral subcapital femoral fracture
* Patients requiring hip replacement (total or partial)
* Signed informed consent from the patient or legal representative
Exclusion Criteria
* Multiple fractures
* Pathological fractures
* Contraceptives or estrogen therapy
* Use of blood salvage during surgery
* History compatible with thromboembolic disease:
* Cerebral vascular accident
* Ischemic heart disease (myocardial infarction, angina )
* Deep vein thrombosis
* Pulmonary Embolism
* Peripheral arterial vasculopathy
* Patients with thrombogenic arrhythmias
* Patients with cardiovascular stents
* Prothrombotic alterations in coagulation
18 Years
ALL
No
Sponsors
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Principal Investigators
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MJ Martínez-Zapata, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Iberoamerican Cochrane Centre. Research Institut Hospital de la Santa Creu i Sant Pau. IIB Sant Pau
Locations
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Hospital Germans Trias i Pujol de Badalona
Badalona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital Clinic
Barcelona, Barcelona, Spain
Parc Taulí
Sabadell, Barcelona, Spain
Hospital Universitari Mútua Terrassa
Terrassa, Barcelona, Spain
Hospital Universitari Terrassa-Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain
Countries
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References
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Martínez-Zapata MJ, Jordán M, Aguilera X, Cánovas E, Urrutia G (en nombre del grupo TRANEXFER). Estudio prospectivo multicéntrico de una cohorte para evaluar la calidad de vida de pacientes intervenidos de fractura subcapital de fémur. Trauma 2014; 25 (4): 188-195.
Merchan-Galvis A, Posso M, Canovas E, Jordan M, Aguilera X, Martinez-Zapata MJ. Quality of life and cost-effectiveness analysis of topical tranexamic acid and fibrin glue in femur fracture surgery. BMC Musculoskelet Disord. 2022 Aug 31;23(1):827. doi: 10.1186/s12891-022-05775-y.
Related Links
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Publication of quality of life (subgroup of patients)
Other Identifiers
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EC11-341
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2011-006278-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SA/12/AYU/456
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
IIBSP-FAT-2011-103
Identifier Type: -
Identifier Source: org_study_id
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