Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Arthrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Topical group

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.

Group Type EXPERIMENTAL

Tranexamic Acid - topical

Intervention Type DRUG

Tranexamic acid is an antifibrinolytic agent that decreases perioperative blood loss, because it inhibits fibrinolysis by competing with lysine molecule in coupling sites in fibrinogen. In this study arm, the drug is administered topically on the wound.

Intravenous group

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.

Group Type ACTIVE_COMPARATOR

Tranexamic Acid - intravenous

Intervention Type DRUG

Tranexamic acid is an antifibrinolytic agent that decreases perioperative blood loss, because it inhibits fibrinolysis by competing with lysine molecule in coupling sites in fibrinogen. In this arm, the drug is administered intravenously.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

100 ml of saline solution administered with anesthesia during 10 minutes

Interventions

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Tranexamic Acid - topical

Tranexamic acid is an antifibrinolytic agent that decreases perioperative blood loss, because it inhibits fibrinolysis by competing with lysine molecule in coupling sites in fibrinogen. In this study arm, the drug is administered topically on the wound.

Intervention Type DRUG

Placebo

100 ml of saline solution administered with anesthesia during 10 minutes

Intervention Type DRUG

Tranexamic Acid - intravenous

Tranexamic acid is an antifibrinolytic agent that decreases perioperative blood loss, because it inhibits fibrinolysis by competing with lysine molecule in coupling sites in fibrinogen. In this arm, the drug is administered intravenously.

Intervention Type DRUG

Other Intervention Names

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trans-4-(aminomethyl)cyclohexanecarboxylic acid Saline solution trans-4-(aminomethyl)cyclohexanecarboxylic acid

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No