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

Sponsor
Xijing Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02504125
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
28.9
Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tranexamic Acid
  • Drug: Normal saline
 Phase 4

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Receving TXA, Study group

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

Drug: Tranexamic Acid
1 g of tranexamic acid in 100 mL of normal saline intravenously approximately 15 minutes before incision
Placebo Comparator: Normal saline, Control group

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

Drug: Normal saline
100 mL of normal saline intravenously approximately 15 minutes before incision

Outcome Measures

Primary Outcome Measures

  1. Rate of Allogeneic Blood Transfusion as a Measure of Efficacy [one week after surgery]

Secondary Outcome Measures

  1. Amount of Total Blood Loss as a Measure of Efficacy [one week after surgery]

  2. Rate of Thrombotic Complications as a Measure of Safety [1 months after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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]).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xijing hospital Xi'an Shaanxi China 710032

Sponsors and Collaborators

  • Xijing Hospital

Investigators

  • Study Director: Jinyu Zhu, M.D., Department of Orthropaedics, Xijing Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chenxiaoyong, Doctor-in-charge, Xijing Hospital
ClinicalTrials.gov Identifier:
NCT02504125
Other Study ID Numbers:
  • XJODCT2014002
First Posted:
Jul 21, 2015
Last Update Posted:
Mar 4, 2016
Last Verified:
Mar 1, 2016
Additional relevant MeSH terms:
Hemorrhage
Tranexamic Acid

Study Results

No Results Posted as of Mar 4, 2016