Efficacy of Intra-auricular Tranexamic Acid in Total Knee Arthroplasty

NCT04085575 | Completed Phase 4 DMC

• 1 other identifier: CHM
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Blood loss in postoperative drainage.

  The primary endpoint was the bleeding represented by blood loss in postoperative drainage.

  Blood loss in 24 hours postoperative drainage

Secondary Outcomes (2)

• The change in hematocrit levels

  change in hematocrit levels at 24 and 72 hours

• The change in hemoglobin levels

  change in hemoglobin levels at 24 and 72 hours

Study Arms (2)

tranexamic acid - The G1 group

ACTIVE COMPARATOR

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

tranexamic acid - The G2 group

ACTIVE COMPARATOR

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

Interventions

Acide Tranexamique DRUG

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.

Also known as: Exacyl

tranexamic acid - The G1 group; tranexamic acid - The G2 group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adult patients undergoing unilateral total knee replacement

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier de Montauban: lead

Study Sites (1)

Edmundo Pereira de Souza Neto

Montauban, Tarn Et Garonne, 82000, France

Location

Related Publications (1)

• 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.

  PMID: 32819728 DERIVED

MeSH Terms

Conditions

Postoperative Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Recruited patients were randomly before the operation by generating random numbers with Microsoft Excel 2007 (Microsoft Corporation, Seattle, Washington, USA).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 11, 2019
• Study Start: January 1, 2019
• Primary Completion: December 9, 2019
• Study Completion: January 9, 2020
• Last Updated: July 14, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)