Efficacy of Intra-auricular Tranexamic Acid in Total Knee Arthroplasty
Primary Purpose
Postoperative Hemorrhage
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Acide Tranexamique
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- Adult patients undergoing unilateral total knee replacement
Exclusion Criteria:
- Absence of consent
- Tranexamic acid allergy
- Coagulopathy (preoperative platelet count <150,000 / mm3, INR [international normalized ratio]> 1.4, or prolonged partial thromboplastin time> 1.4 times normal),
- History of arterial or venous thromboembolic disease (cerebrovascular accident, deep vein thrombosis or pulmonary thromboembolism),
- Hematological disorder (a hematopoietic, hemorrhagic or thrombogenic disease),
- Retinopathy (severe limitation of the field of vision and / or color distortion),
- Refusal to receive blood products
- Pregnancy
- History of convulsions
- Participation in another clinical trial.
Sites / Locations
- Edmundo Pereira de Souza Neto
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
tranexamic acid - The G1 group
tranexamic acid - The G2 group
Arm Description
The G1 group received 1 g of intra-articular tranexamic acid (TXA). The G1 group received 15 mg / kg IV at 20 min at induction and then 10 mg / kg in oral administration 6 and 12 hours after induction dose IV of tranexamic acid.
The G2 group received 2 g of intra-articular tranexamic acid (TXA). The G2 group received 15 mg / kg IV at 20 min at induction and then 10 mg / kg in oral administration 6 and 12 hours after induction dose IV of tranexamic acid.
Outcomes
Primary Outcome Measures
Blood loss in postoperative drainage.
The primary endpoint was the bleeding represented by blood loss in postoperative drainage.
Secondary Outcome Measures
The change in hematocrit levels
The secondary outcomes were the change in hematocrit levels.
The change in hemoglobin levels
The secondary outcomes were the change in hemoglobin levels.
Full Information
NCT ID
NCT04085575
First Posted
August 29, 2019
Last Updated
July 13, 2020
Sponsor
Centre Hospitalier de Montauban
1. Study Identification
Unique Protocol Identification Number
NCT04085575
Brief Title
Efficacy of Intra-auricular Tranexamic Acid in Total Knee Arthroplasty
Official Title
Efficacy of 1g Versus 2g Intra-auricular Tranexamic Acid in Postoperative Bleeding After Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 9, 2019 (Actual)
Study Completion Date
January 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier de Montauban
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Tranexamic acid an antifibrinolytic that develops its anti-haemorrhagic action by inhibiting fibrinolytic activities of plasmin and many studies confirms its effectiveness in decreasing blood loss. The aim of this study was to observe postoperative bleeding with combined intravenous and per - os administration with two intra - articular doses (1 g and 2 g) of tranexamic acid in adult patients undergoing unilateral total knee replacement.
Detailed Description
Total knee arthroplasty (TKA) is widely used as an effective treatment for end-stage osteoarthritis and other joint diseases of the knee and it improvements in surgical materials and techniques have greatly increased its effectiveness. However, TKA is an orthopaedic surgical method that has a substantial perioperative blood loss.
Classical methods for reducing blood loss and transfusion rate include the use of a pneumatic tourniquet, intraoperative cell saver, hypotensive anesthesia, application of erythropoietin, autologous blood transfusion, plugging of the femoral canal, cementing, drain clamping, navigation and minimally invasive surgery.
Tranexamic acid (TXA) an antifibrinolytic that develops its anti-haemorrhagic action by inhibiting fibrinolytic activities of plasmin has been used as an adjuvant to such measure and many studies with a level of evidence confirms its effectiveness in decreasing blood loss.
Fibrinolysis is stimulated by surgical trauma blood loss and TKA may be related to increased fibrinolytic activity. TXA inhibits fibrinolysis by blocking the lysine-binding sites of plasminogen to fibrin. Plasmin, bound to tranexamic acid, has a considerably diminished activity with respect to fibrin compared to that of free plasmin. Also, it appears from various studies that, in vivo, tranexamic acid at high doses exerts a braking activity on the activation of the complement system. So, TXA reduces bleeding in the TKA and its functional repercussion has also been confirmed in assays for various dosages and routes of administration.
In the literature, efficacy of intra-articular TXA has also been confirmed, but what is the right dosage is now unclear.
The aim of this study was to observe postoperative bleeding with combined intravenous and per - os administration with two intra - articular doses (1 g and 2 g) of tranexamic acid (Sanofi-Aventis® Gentilly, France).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
They were assigned in two groups: The G1 group received 1 g of intra-articular tranexamic acid (TXA) and the G2 group received 2 g of intra-articular tranexamic acid. Both groups received 15 mg / kg IV at 20 min at induction and then 10 mg / kg in oral administration 6 and 12 hours after induction dose IV of tranexamic acid.
Masking
ParticipantCare Provider
Masking Description
Recruited patients were randomly before the operation by generating random numbers with Microsoft Excel 2007 (Microsoft Corporation, Seattle, Washington, USA).
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tranexamic acid - The G1 group
Arm Type
Active Comparator
Arm Description
The G1 group received 1 g of intra-articular tranexamic acid (TXA). The G1 group received 15 mg / kg IV at 20 min at induction and then 10 mg / kg in oral administration 6 and 12 hours after induction dose IV of tranexamic acid.
Arm Title
tranexamic acid - The G2 group
Arm Type
Active Comparator
Arm Description
The G2 group received 2 g of intra-articular tranexamic acid (TXA). The G2 group received 15 mg / kg IV at 20 min at induction and then 10 mg / kg in oral administration 6 and 12 hours after induction dose IV of tranexamic acid.
Intervention Type
Drug
Intervention Name(s)
Acide Tranexamique
Other Intervention Name(s)
Exacyl
Intervention Description
Recruited patients were randomly before the operation by generating random numbers with Microsoft Excel 2007. They were assigned in two groups: 1 g of intra-articular tranexamic acid (TXA) and 2 g of intra-articular tranexamic acid.
Primary Outcome Measure Information:
Title
Blood loss in postoperative drainage.
Description
The primary endpoint was the bleeding represented by blood loss in postoperative drainage.
Time Frame
Blood loss in 24 hours postoperative drainage
Secondary Outcome Measure Information:
Title
The change in hematocrit levels
Description
The secondary outcomes were the change in hematocrit levels.
Time Frame
change in hematocrit levels at 24 and 72 hours
Title
The change in hemoglobin levels
Description
The secondary outcomes were the change in hemoglobin levels.
Time Frame
change in hemoglobin levels at 24 and 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Adult patients undergoing unilateral total knee replacement
Exclusion Criteria:
Absence of consent
Tranexamic acid allergy
Coagulopathy (preoperative platelet count <150,000 / mm3, INR [international normalized ratio]> 1.4, or prolonged partial thromboplastin time> 1.4 times normal),
History of arterial or venous thromboembolic disease (cerebrovascular accident, deep vein thrombosis or pulmonary thromboembolism),
Hematological disorder (a hematopoietic, hemorrhagic or thrombogenic disease),
Retinopathy (severe limitation of the field of vision and / or color distortion),
Refusal to receive blood products
Pregnancy
History of convulsions
Participation in another clinical trial.
Facility Information:
Facility Name
Edmundo Pereira de Souza Neto
City
Montauban
State/Province
Tarn Et Garonne
ZIP/Postal Code
82000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The aim of our study was to observe postoperative bleeding with combined intravenous and per - os administration with two intra - articular doses (1 g and 2 g) of tranexamic acid.
Citations:
PubMed Identifier
32819728
Citation
Souza Neto EP, Usandizaga G. [Comparison of two doses of intra-articular tranexamic acid on postoperative bleeding in total knee arthroplasty: a randomized clinical trial]. Braz J Anesthesiol. 2020 Jul-Aug;70(4):318-324. doi: 10.1016/j.bjan.2020.03.015. Epub 2020 Jul 8.
Results Reference
derived
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Efficacy of Intra-auricular Tranexamic Acid in Total Knee Arthroplasty
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