The Efficacy and Safety of Using Tranexamic Acid to Reduce Blood Loss In Simultaneous Bilateral Total Knee Arthroplasty

NCT02504125 | Completed Phase 4 DMC

• 1 other identifier: XJODCT2014002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, single-center and controlled study comparing the efficacy and safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous bilateral total knee arthroplasty.

Conditions

Blood Loss

Outcome Measures

Primary Outcomes (1)

• Rate of Allogeneic Blood Transfusion as a Measure of Efficacy

  one week after surgery

Secondary Outcomes (2)

• Amount of Total Blood Loss as a Measure of Efficacy

  one week after surgery

• Rate of Thrombotic Complications as a Measure of Safety

  1 months after surgery

Study Arms (2)

Receving TXA, Study group

EXPERIMENTAL

Tranexamic acid, Study group tranexamic acid 1g, intravenous injection, pre-operationally

Drug: Tranexamic Acid

Normal saline, Control group

PLACEBO COMPARATOR

Not receiving tranexamic acid, Control group Normal saline 100mL, intravenous injection, pre-operationally

Drug: Normal saline

Interventions

Tranexamic Acid DRUG

1 g of tranexamic acid in 100 mL of normal saline intravenously approximately 15 minutes before incision

Receving TXA, Study group

Normal saline DRUG

100 mL of normal saline intravenously approximately 15 minutes before incision

Normal saline, Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who plan to undergo simultaneous primary total knee arthroplasty on bilateral knee joint with a diagnosis of osteoarthritis or aseptic bone necrosis, but not of rheumatoid arthritis;
• All patients who have normal preoperative platelet count, normal prothrombin time, normal partial thromboplastin time, and normal international normalized ratio;
• The use of only balanced electrolyte solutions and/or albumin for plasma volume restitution

You may not qualify if:

• Allergy to tranexamic acid;
• Receiving warfarin or heparin; had a history of hemophilia, deep venous thrombosis, pulmonary embolism, or renal impairment; or were pregnant;
• Patients with any cardiovascular problems (such as myocardiac infarction history, atrial fibrillation, angina);
• Patients with thromboembolic disorders, or those exhibiting a deteriorating general condition;
• Preoperative anemia (a hemoglobin value of \<11 g/dL in females and \<12 g/dL in males), refusal of blood products;
• Preoperative use of anticoagulant therapy within five days before surgery, fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy (as identified by a preoperative platelet count of \<150,000/mm3, an international normalized ratio of \>1.4, or a prolonged partial thromboplastin time \[\>1.4 times normal\]).

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jinyu Zhu, M.D.

  Department of Orthropaedics, Xijing Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor-in-charge

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: July 21, 2015
• Study Start: January 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2015
• Last Updated: March 4, 2016

Record last verified: 2016-03

Locations

CN (1)