Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty

NCT02323373 | Completed Phase 2

• 1 other identifier: ISCMSP
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Arthrosis

Keywords

Arthroplasty, Replacement, Knee; Tranexamic Acid; Drug Administration Routes

Outcome Measures

Primary Outcomes (1)

• Blood loss

  Volume of blood loss in the suction drain device after TKA surgery

  up to 48 hours from the end of surgery, with drained volume registered every 6 hours.

Secondary Outcomes (2)

• Thrombosis

  up to 15 days after surgery

• Need for transfusion

  during or after surgery, during hospital stay (hospital discharge took place in four days, in average)

Study Arms (3)

Topical group

EXPERIMENTAL

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.

Drug: Tranexamic Acid - topical

Intravenous group

ACTIVE COMPARATOR

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.

Drug: Tranexamic Acid - intravenous

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Tranexamic Acid - topical 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.

Also known as: trans-4-(aminomethyl)cyclohexanecarboxylic acid

Topical group

Placebo DRUG

100 ml of saline solution administered with anesthesia during 10 minutes

Also known as: Saline solution

Placebo

Tranexamic Acid - intravenous 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.

Also known as: trans-4-(aminomethyl)cyclohexanecarboxylic acid

Intravenous group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Irmandade da Santa Casa de Misericordia de Sao Paulo: lead

MeSH Terms

Conditions

Osteoarthritis

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Zekcer Ari, MD, PhD

  Santa Casa de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 23, 2014
• Study Start: June 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 14, 2015

Record last verified: 2015-01