- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02051686
Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid (TXA)
Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid: A Prospective, Randomized, Controlled Study
This study is investigating the use of tranexamic acid (TXA) in patients with pelvis and/or hip socket fractures that require surgery. TXA is FDA-approved in patients with hemophilia for short-term use to reduce hemorrhage and the need for replacement blood during tooth extraction. However, it has also been used extensively in severely injured patients after major trauma and during elective hip and knee replacements. Previous studies indicate TXA may reduce blood loss and the need for blood transfusions while being safe for use in most patients. TXA is fairly inexpensive and easy to obtain.
The purpose of this study is to determine if TXA will make surgery in patients with pelvis and/or hip socket fractures safer and more cost efficient.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Missouri
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Columbia, Missouri, United States, 65212
- University of Missouri
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patients (18 years of age or greater) with acetabulum fractures and/or pelvic ring injuries that require operative fixation via an open surgical approach
Exclusion Criteria:
- Revision surgery
- Surgery occurring more than 2 weeks post-injury
- History of blood dyscrasia or renal insufficiency
- History of any thromboembolic disease
- Pregnancy or nursing, color vision defects
- History of retinal detachment/degeneration
- Intracranial hemorrhage
- Hypersensitivity to tranexamic acid
- Contraceptive Use (estrogens/progestins)
- FEIBA (anti-inhibitor coagulant complex) use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Tranexamic Acid
Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.
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10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.
Other Names:
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PLACEBO_COMPARATOR: Placebo
The control group will receive a similar volume load of normal saline and maintenance doses.
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The control group will receive a similar volume load of normal saline and maintenance doses.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intra-operative Blood Loss
Time Frame: Day of Surgery
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Day of Surgery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants That Required an Allogenic Transfusion
Time Frame: Perioperative (hospitalized period)
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Perioperative (hospitalized period)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1208444
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acetabulum Fractures
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Groupe Hospitalier Paris Saint JosephCompletedFractures | AcetabulumFrance
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Groupe Hospitalier Paris Saint JosephCompleted
-
Peifu TangCompletedFracture of AcetabulumChina
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Zimmer BiometActive, not recruitingAcetabulum Fracture | Pelvic Ring FractureItaly
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The University of Texas Health Science Center,...TerminatedIntra-Articular Fractures | Acetabulum | Fracture FixationUnited States
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Fondation Hôpital Saint-JosephCompletedTransverse Fracture of AcetabulumFrance
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Rijnstate HospitalNoordwest Ziekenhuisgroep; Maxima Medical Center; Jeroen Bosch Ziekenhuis; IsalaNot yet recruitingHemiarthroplasty | Femoral Neck Fractures | Acetabulum; ProtrusionNetherlands
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MetroHealth Medical CenterCompletedFemur Fracture | Unstable Pelvic Ring Fracture | Unstable Acetabulum FractureUnited States
-
University of CincinnatiFoundation for Orthopedic TraumaRecruitingFracture of Posterior Wall of AcetabulumUnited States
Clinical Trials on Tranexamic Acid
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Icahn School of Medicine at Mount SinaiRecruiting
-
University of LiegeCompletedArthroplasty Complications | Hemorrhage Postoperative | Total Blood LossBelgium
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London School of Hygiene and Tropical MedicineCompleted
-
Samsung Medical CenterUnknownBleeding | Transfusion Related ComplicationKorea, Republic of
-
Ain Shams UniversityCompleted
-
Aswan University HospitalCompletedCesarean Section ComplicationsEgypt
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Assiut UniversityCompleted
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London School of Hygiene and Tropical MedicineRawalpindi Medical CollegeCompletedPregnancy, High RiskPakistan, Zambia
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Thammasat UniversityCompleted
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Ferring PharmaceuticalsCompleted