Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty (TRANEXTKA)

Irmandade da Santa Casa de Misericordia de Sao Paulo

Status and phase: Completed; Phase 2

Conditions: Arthrosis

Treatments: Drug: Tranexamic Acid - topical; Drug: Tranexamic Acid - intravenous; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02323373

ISCMSP

Details and patient eligibility

About

This clinical trial investigated two different routes of administration of tranexamic acid in total knee arthroplasty: topical compared to intravenous.

Full description

Intravenous administration of tranexamic acid (TA) is common in orthopedic surgery. The ideal dose and administration route of the drug in total knee arthroplasty (TKA) is under investigation.

The objective of this randomized clinical trial was to verify differences between topical and intravenous administration of TA in TKA regarding blood loss and coagulation variables.

Patients undergoing TKA were randomized to receive TA intravenously (20 mg in 100 ml of saline), topically (1.5 g in 50 ml of saline, sprayed over the operated site, before closure) or intravenous saline (100 ml). Suction drains were maintained for 48 hours, in order to measure blood loss. Data analysis is being undertaken now, in order to compare the two routes of administration of the drug.

Enrollment: 90 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Patients in need of unilateral total knee arthroplasty (TKA) due to arthrosis, Albach grades III and IV were eligible

Exclusion Criteria:

• history or identified risk for deep vein thrombosis or pulmonary embolism
• history of coagulation or cardiovascular disorders
• vascular diseases
• pregnancy
• current use of anticoagulation drugs
• previous orthopedic surgery in the legs.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups, including a placebo group

Topical group

Experimental group

Description:

Intervention: Tranexamic Acid - topical. Topical administration of a solution of 1.5 g of tranexamic acid (50 mg/ml, Transamin, Zydus Nikkho) diluted in 50 ml of saline (at 0.9%), sprayed over the operated area, covering it for 5 minutes, before the tourniquet release.

Treatment:

Drug: Tranexamic Acid - topical

Intravenous group

Active Comparator group

Description:

Intervention: Tranexamic Acid - intravenous Intravenous injection of 20 mg/kg of tranexamic acid, diluted in 100 ml of saline at 0.9%, administered with anesthesia in 10 minutes.

Treatment:

Drug: Tranexamic Acid - intravenous

Placebo

Placebo Comparator group

Description:

Intervention: intravenous injection of 100 ml of saline solution also administered with anesthesia in 10 minutes.

Treatment:

Drug: Placebo