Use of Transexamic Acid in Hip Replacement

NCT02587845 | Unknown Phase 3 DMC

• 1 other identifier: 2014-01-129
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Studies have shown that tranexamic acid reduces blood loss and transfusion need in patients undergoing total hip arthroplasty. However, no to date, no study has been large enough to determine definitively whether the drug is safe and effective. The present study was designed to verify noninferior efficacy and safety of topical intra-articular TXA compared with intravenous TXA in primary THA.

Conditions

Bleeding; Transfusion Related Complication

Keywords

total hip arthroplasty; transexamic acid

Outcome Measures

Primary Outcomes (1)

• Bleeding

  Surgical bleeding

  intraoperatively

Secondary Outcomes (1)

• Total Transfusion

  5days after surgery

Other Outcomes (1)

• Operation time

  intraoperatively

Study Arms (2)

IV group

ACTIVE COMPARATOR

Intravenous tranexamic acid injection Group IV tranexamic acid group were administered intravenous 10 mg/kg dose of TXA after closing the ITB.

Drug: Tranexamic Acid (IV)

Topical group

EXPERIMENTAL

Intra-articular tranexamic acid injection Group Topical tranexamic acid group were administered 2.0 g TXA in 100 ml of normal saline into the hemovac line after closing the ITB.

Drug: Tranexamic Acid (Topical)

Interventions

Tranexamic Acid (IV) DRUG

IV tranexamic acid group were administered intravenous 10 mg/kg dose of TXA after closing the ITB.

Also known as: TXA

IV group

Tranexamic Acid (Topical) DRUG

Topical tranexamic acid group were administered 2.0 g TXA in 100 ml of normal saline into the hemovac line after closing the ITB.

Also known as: TXA

Topical group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral primary THA
• Diagnosis - not fracture, elective surgery
• Revision THA

You may not qualify if:

• Known allergy to TNA
• Acquired or congenital coagulopathy
• Current anticoagulation therapy
• Preoperative hepatic or renal dysfunction
• Severe ischemic heart disease (Serious cardiac or respiratory disease)
• A history of thromboembolic disease
• Refusal of blood products
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-700, South Korea

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Youn Soo Park, MD

  Samsung Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: October 27, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 27, 2015

Record last verified: 2015-10

Locations

KR (1)