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Trial record 4 of 419 for:    TRANEXAMIC ACID

TRANEXAMIC ACID IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY IN A BRAZILIAN REFERENCE ORTHOPEDIC CENTER: A RANDOMIZED CONTROLLED TRIAL

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ClinicalTrials.gov Identifier: NCT03019198
Recruitment Status : Completed
First Posted : January 12, 2017
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Osamu de Sandes Kimura, Instituto Nacional de Traumatologia e Ortopedia

Brief Summary:
This study aims to analyze the efficacy of intravenous tranexamic acid (TXA) in patients undergoing total hip arthroplasty (THA).

Condition or disease Intervention/treatment Phase
Blood Loss, Surgical Tranexamic Acid Adverse Reaction Hip Replacement Drug: Tranexamic Acid Injectable Solution Drug: Placebo - Concentrate Phase 4

Detailed Description:

This was a prospective, experimental, randomized, controlled study of 308 consecutive patients who underwent primary THA from December 2013 to March 2014. 256 volunteers remained in the study, 128 were treated 15 mg/kg intravenous bolus of TXA and 128 did not receive the medication. Participants were followed up at 3 weeks, 3 months, 6 months, 1 year, and then annually after surgery.

The use of TXA resulted in lesser reduction in hemoglobin and hematocrit levels, reduced blood loss, blood transfusion rate, volume of blood products, and stay length even in risk factor patients.

TXA protects risk factor patients against intra and postoperative bleeding and reduces transfusion rates.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: TRANEXAMIC ACID IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY IN A BRAZILIAN REFERENCE ORTHOPEDIC CENTER: A RANDOMIZED CONTROLLED TRIAL
Study Start Date : December 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TXA
Performed an intravenous bolus administration of 15 mg/kg of TXA to the volunteers after the end of the anesthesia and 15 minutes prior to skin incision.
Drug: Tranexamic Acid Injectable Solution
Intravenous 15 mg per kilogram tranexamic acid
Other Names:
  • Lysteda
  • Transamin

Placebo Comparator: Control
This group underwent the same procedures of the TXA group, excepting the preoperative administration of the medication.
Drug: Placebo - Concentrate



Primary Outcome Measures :
  1. Hemoglobin drop [ Time Frame: 24 hours post operative ]
  2. Hematocrit drop [ Time Frame: 24 hours post operative ]
  3. Blood transfusion rate [ Time Frame: 5 days ]
  4. Operative blood loss [ Time Frame: 24 hours post operative ]

Secondary Outcome Measures :
  1. Length of stay in hospital [ Time Frame: 7 days ]
  2. Systemic adverse events [ Time Frame: 1 year ]
  3. Thromboembolic efects [ Time Frame: 1 year ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Consecutive patients who need total hip replacement were included in the initial sample. There was no age limit or restriction regarding gender for admission to the study.

Exclusion Criteria:

  • Patients who underwent previous surgery in the same joint, evidence of joint infection, congenital or acquired coagulopathies, active intravascular coagulation, acute occlusive vasculopathy, hypersensitivity to TXA, chronic use of oral and steroid anticoagulants, history of severe or moderate allergy to plasma transfusion, chronic heart disease, malignant neoplasms and autoimmune diseases, patients who needed bone graft or underwent hip arthroplasty revision surgeries, and who did not consent to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019198


Locations
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Brazil
Instituto Nacional de Traumatologia e Ortopedia
Rio de Janeiro, Brazil, 20940070
Sponsors and Collaborators
Instituto Nacional de Traumatologia e Ortopedia

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Responsible Party: Osamu de Sandes Kimura, M.D., Instituto Nacional de Traumatologia e Ortopedia
ClinicalTrials.gov Identifier: NCT03019198     History of Changes
Other Study ID Numbers: 06554913.0.0000.5273
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Osamu de Sandes Kimura, Instituto Nacional de Traumatologia e Ortopedia:
Tranexamic Acid
Blood loss
Tranfusion
Additional relevant MeSH terms:
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Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants