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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||256 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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
Placebo Comparator: Control
This group underwent the same procedures of the TXA group, excepting the preoperative administration of the medication.
Drug: Placebo - Concentrate
- Hemoglobin drop [ Time Frame: 24 hours post operative ]
- Hematocrit drop [ Time Frame: 24 hours post operative ]
- Blood transfusion rate [ Time Frame: 5 days ]
- Operative blood loss [ Time Frame: 24 hours post operative ]
- Length of stay in hospital [ Time Frame: 7 days ]
- Systemic adverse events [ Time Frame: 1 year ]
- Thromboembolic efects [ Time Frame: 1 year ]
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
|Instituto Nacional de Traumatologia e Ortopedia|
|Rio de Janeiro, Brazil, 20940070|