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The Efficacy and Safety of Using Tranexamic Acid by Different Means to Reduce Blood Loss During Total Knee Replacement

Primary Purpose

Blood Loss

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

About this trial

This is an interventional treatment trial for Blood Loss focused on measuring Tranexamic Acid, Antifibrinolytic, Blood transfusion, Total knee arthroplasty

Eligibility Criteria

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

Inclusion Criteria:

  • Adult patients who plan to undergo primary total knee arthroplasty on unilateral 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 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Tranexamic acid, IA group

Tranexamic acid, IV group

Tranexamic acid, IV+IA group

Arm Description

Tranexamic acid 1g, intra-articular injection, post-operationally

Tranexamic acid, 1g, intravenous injection, post-operationally

Tranexamic acid, 1g, intravenous injection, post-operationally; Tranexamic acid, 1g, intra-articular injection, post-operationally

Outcomes

Primary Outcome Measures

Average amounts of transfusion

Secondary Outcome Measures

Calculated blood loss
thrombosis

Full Information

First Posted
April 15, 2014
Last Updated
March 3, 2016
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02117128
Brief Title
The Efficacy and Safety of Using Tranexamic Acid by Different Means to Reduce Blood Loss During Total Knee Replacement
Official Title
The Efficacy and Safety of Using Tranexamic Acid by Different Means to Reduce Blood Loss During Total Knee Replacement: a Randomized, Double-blind, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 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
We will investigate the efficacy and safety of using tranexamic acid by intravenous, intra-articular and combinational administration to reduce blood loss during total knee replacement. We hypothesize a combined intra-articular and single intravenous dose protocol of tranexamic acid may achieve a higher therapeutic concentration at the intra-articular and extra-articular bleeding site with little or no systemic absorption and subsequent systemic side effects.
Detailed Description
A randomized, double-blind, single-center, controlled and parallel-assigned study comparing the efficacy and safety of intravenous, intra-articular and combinational administration of tranexamic acid to reduce blood loss during total knee replacement. Subjects will be monitored for occurrence of any complications, particularly deep venous thrombosis and thromboembolism during the hospital stay and for 3 months postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss
Keywords
Tranexamic Acid, Antifibrinolytic, Blood transfusion, Total knee arthroplasty

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid, IA group
Arm Type
Experimental
Arm Description
Tranexamic acid 1g, intra-articular injection, post-operationally
Arm Title
Tranexamic acid, IV group
Arm Type
Active Comparator
Arm Description
Tranexamic acid, 1g, intravenous injection, post-operationally
Arm Title
Tranexamic acid, IV+IA group
Arm Type
Experimental
Arm Description
Tranexamic acid, 1g, intravenous injection, post-operationally; Tranexamic acid, 1g, intra-articular injection, post-operationally
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid
Primary Outcome Measure Information:
Title
Average amounts of transfusion
Time Frame
one week after surgery
Secondary Outcome Measure Information:
Title
Calculated blood loss
Time Frame
one week after surgery
Title
thrombosis
Time Frame
3 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 primary total knee arthroplasty on unilateral 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]).
Facility Information:
Facility Name
Xijing hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

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The Efficacy and Safety of Using Tranexamic Acid by Different Means to Reduce Blood Loss During Total Knee Replacement

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