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

Primary Purpose

Blood Loss

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tranexamic Acid
Normal saline
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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]).

Sites / Locations

  • Xijing hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Receving TXA, Study group

Normal saline, Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rate of Allogeneic Blood Transfusion as a Measure of Efficacy

Secondary Outcome Measures

Amount of Total Blood Loss as a Measure of Efficacy
Rate of Thrombotic Complications as a Measure of Safety

Full Information

First Posted
June 23, 2015
Last Updated
March 3, 2016
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02504125
Brief Title
The Efficacy and Safety of Using Tranexamic Acid to Reduce Blood Loss In Simultaneous Bilateral Total Knee Arthroplasty
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 Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Receving TXA, Study group
Arm Type
Experimental
Arm Description
Tranexamic acid, Study group tranexamic acid 1g, intravenous injection, pre-operationally
Arm Title
Normal saline, Control group
Arm Type
Placebo Comparator
Arm Description
Not receiving tranexamic acid, Control group Normal saline 100mL, intravenous injection, pre-operationally
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
1 g of tranexamic acid in 100 mL of normal saline intravenously approximately 15 minutes before incision
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
100 mL of normal saline intravenously approximately 15 minutes before incision
Primary Outcome Measure Information:
Title
Rate of Allogeneic Blood Transfusion as a Measure of Efficacy
Time Frame
one week after surgery
Secondary Outcome Measure Information:
Title
Amount of Total Blood Loss as a Measure of Efficacy
Time Frame
one week after surgery
Title
Rate of Thrombotic Complications as a Measure of Safety
Time Frame
1 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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]).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinyu Zhu, M.D.
Organizational Affiliation
Department of Orthropaedics, Xijing Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Xijing hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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