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Efficacy of Intra-auricular Tranexamic Acid in Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT04085575
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier de Montauban

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.

Condition or disease Intervention/treatment Phase
Postoperative Hemorrhage Drug: Acide Tranexamique Phase 4

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Care Provider)
Masking Description: Recruited patients were randomly before the operation by generating random numbers with Microsoft Excel 2007 (Microsoft Corporation, Seattle, Washington, USA).
Primary Purpose: Treatment
Official Title: Efficacy of 1g Versus 2g Intra-auricular Tranexamic Acid in Postoperative Bleeding After Total Knee Arthroplasty
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : September 9, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: tranexamic acid - The G1 group
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.
Drug: Acide Tranexamique
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.
Other Name: Exacyl

Active Comparator: tranexamic acid - The G2 group
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.
Drug: Acide Tranexamique
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.
Other Name: Exacyl




Primary Outcome Measures :
  1. Blood loss in postoperative drainage. [ Time Frame: Blood loss in 24 hours postoperative drainage ]
    The primary endpoint was the bleeding represented by blood loss in postoperative drainage.


Secondary Outcome Measures :
  1. The change in hematocrit levels [ Time Frame: change in hematocrit levels at 24 and 72 hours ]
    The secondary outcomes were the change in hematocrit levels.

  2. The change in hemoglobin levels [ Time Frame: change in hemoglobin levels at 24 and 72 hours ]
    The secondary outcomes were the change in hemoglobin levels.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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): NCT04085575


Contacts
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Contact: Edmundo P Souza Neto, Ph.D, M.D. 33563928336 edmundo.pereira-de-souza@hotmail.fr

Locations
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France
Edmundo Pereira de Souza Neto Recruiting
Montauban, Tarn Et Garonne, France, 82000
Contact: Edmundo P SOUZA NETO, PhD    335.63.92.83.36    edmundo.pereira-de-souza@hotmail.fr   
Contact: Gorka P USANDIZAGA, MD    33 5 63 92 82 82    g.usandizaga@ch-montauban.fr   
Sponsors and Collaborators
Centre Hospitalier de Montauban

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Responsible Party: Centre Hospitalier de Montauban
ClinicalTrials.gov Identifier: NCT04085575     History of Changes
Other Study ID Numbers: CHM
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhage
Postoperative Hemorrhage
Pathologic Processes
Postoperative Complications
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants