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Trial record 9 of 428 for:    TRANEXAMIC ACID

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

Tracking Information
First Submitted Date  ICMJE August 29, 2019
First Posted Date  ICMJE September 11, 2019
Last Update Posted Date September 11, 2019
Actual Study Start Date  ICMJE January 1, 2019
Actual Primary Completion Date September 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Intra-auricular Tranexamic Acid in Total Knee Arthroplasty
Official Title  ICMJE Efficacy of 1g Versus 2g Intra-auricular Tranexamic Acid in Postoperative Bleeding After Total Knee Arthroplasty
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Postoperative Hemorrhage
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Acide Tranexamique
  • 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.
    Intervention: Drug: Acide Tranexamique
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 10, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2019
Actual Primary Completion Date September 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Edmundo P Souza Neto, Ph.D, M.D. 33563928336 edmundo.pereira-de-souza@hotmail.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04085575
Other Study ID Numbers  ICMJE CHM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Centre Hospitalier de Montauban
Study Sponsor  ICMJE Centre Hospitalier de Montauban
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier de Montauban
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP