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

Blood Loss Clinical Trial

Official title:

The Efficacy and Safety of Using Tranexamic Acid to Reduce Blood Loss In Simultaneous Bilateral Total Knee Arthroplasty: a Randomized, Double-blind, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504125
• Other study ID #: XJODCT2014002
• Status: Completed
• Phase: Phase 4
• First received: June 23, 2015
• Last updated: March 3, 2016
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: March 2016
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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. Subjects will be monitored for occurrence of any complications, particularly deep venous thrombosis and thromboembolism during the hospital stay and for 1 months postoperatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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]).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage

Intervention

Drug:
• Tranexamic Acid
1 g of tranexamic acid in 100 mL of normal saline intravenously approximately 15 minutes before incision
• Normal saline
100 mL of normal saline intravenously approximately 15 minutes before incision

Locations

Country	Name	City	State
China	Xijing hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Allogeneic Blood Transfusion as a Measure of Efficacy		one week after surgery	No
Secondary	Amount of Total Blood Loss as a Measure of Efficacy		one week after surgery	No
Secondary	Rate of Thrombotic Complications as a Measure of Safety		1 months after surgery	Yes