Comparison of Topical and Infusion Tranexamic Acid After Total Knee Arthroplasty

May 26, 2015 updated by: Wang Jun-Wen, Chang Gung Memorial Hospital

Comparison of Topical and Infusion Tranexamic Acid on Blood Loss and Risk of Deep Vein Thrombosis After Total Knee Arthroplasty

The purpose of the study, therefore, is to conduct a prospective randomized controlled trial to investigate the blood-conservation effect of TXA in different TKA patients groups with rivaroxaban for VTE prophylaxis, first group by topical application, second group by infusion and a third group of placebo and observe whether there is difference in the occurrence of venous thromboembolism in those patient groups by venographic study

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Investigators previous experiences in minimally invasive (MIS) TKA showed that intraoperative infusion of TXA reduced 45% of postoperative blood loss and needs for transfusion from 20% to 4%. However, most of the orthopedic surgeons still hesitate to use TXA systemically in TKAs especially in high risk patients with a potential increase in thromboembolic events following surgery.

Because of this concern, recently, there were few reports demonstrating the cost-effectiveness of topical application of TXA in TKA patients. However, most of the reports compared the topical TXA with placebo in TKA patients, not with intravenous TXA. Recently, Georgiadis et al. conducted a double-blind, randomized controlled clinical trial are demonstrated similar transfusion rate and perioperative blood loss between topical administration and intravenous injection of TXA in TKA patients. There were no significant safety differences between the two groups. Low-molecular weight heparin (LMWH) was used for thromboembolism prophylaxis in that study.

Recently, chemical VTE prophylaxis such as rivaroxaban has been approved as a standard care after TKA because of its superior convenience and efficacy on VTE prophylaxis to LMWH in TKAs. However, because of direct blockage of the formation of thrombin from prothrombin by rivaroxaban, an increased postoperative bleeding has been reported. There have been little studies investigating the blood-conservation effect of TXA on TKA patients either by infusion or by topical application when rivaroxaban used as VTE prophylaxis.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Koahsiung, Taiwan
        • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • End-stage arthritis of the knee
  • Failure of medical treatment or rehabilitation
  • Hemoglobin > 10g/dl
  • No use of non-steroid anti-inflammatory agent one week before operation

Exclusion Criteria:

  • Preoperative Hemoglobin ≦10 g/dl
  • History of infection or intraarticular fracture of the affective knee
  • Renal function deficiency (GFR < 55 ml/min/1.73m2)which is relative contraindicated for venography
  • Elevated liver enzyme, history of liver cirrhosis, impaired liver function and coagulopathy (including long-term use anticoagulant)
  • History of deep vein thrombosis, ischemic heart disease or stroke

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Topic TXA group

Primary total knee replacement with intravenous 0.9% normal saline (20 ml) administration before deflation of the tourniquet and intraarticular application of Tranexamic Acid 5%,5ml/amp 3g (60ml) in 100 ml normal saline into knee joint after closure of the joint capsule

Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis
Drug: Tranexamic Acid 5%,5ml/amp
Intraarticular application of tranexamic acid 3g (60ml) in 100 ml normal saline into knee joint after closure of the joint capsule
Other Names:
  • Transamine
Drug: Tranexamic Acid 5%,5ml/amp
IV TXA group: Primary total knee replacement with 1 g tranexamic acid administrated intravenously before deflection of the tourniquet
Other Names:
  • Transamine
Drug: rivaroxaban (10mg)
Oral rivaroxabam (10mg) QD on PostOp Day 1 to 14.
Other Names:
  • Xarelto
Drug: 0.9% Normal Saline
Primary total knee replacement with intravenous normal saline (20 ml) administration before deflation of the tourniquet
Other Names:
  • 0.9% sodium chloride
Drug: 0.9% Normal Saline
Topical 160 ml normal saline application after closure of joint capsule.
Other Names:
  • 0.9% sodium chloride
Active Comparator: IV TXA group

Primary total knee replacement with 1 g Tranexamic Acid 5%,5ml/amp administrated intravenously before deflection of the tourniquet and topical 160 ml 0.9% normal saline application after closure of joint capsule.

Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis
Drug: Tranexamic Acid 5%,5ml/amp
Intraarticular application of tranexamic acid 3g (60ml) in 100 ml normal saline into knee joint after closure of the joint capsule
Other Names:
  • Transamine
Drug: Tranexamic Acid 5%,5ml/amp
IV TXA group: Primary total knee replacement with 1 g tranexamic acid administrated intravenously before deflection of the tourniquet
Other Names:
  • Transamine
Drug: rivaroxaban (10mg)
Oral rivaroxabam (10mg) QD on PostOp Day 1 to 14.
Other Names:
  • Xarelto
Drug: 0.9% Normal Saline
Primary total knee replacement with intravenous normal saline (20 ml) administration before deflation of the tourniquet
Other Names:
  • 0.9% sodium chloride
Drug: 0.9% Normal Saline
Topical 160 ml normal saline application after closure of joint capsule.
Other Names:
  • 0.9% sodium chloride
Placebo Comparator: Control group

Primary total knee replacement with 0.9% normal saline administration intravenously before deflation of the tourniquet and topical 160 ml 0.9% normal saline application after closure of joint capsule.

Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis
Drug: rivaroxaban (10mg)
Oral rivaroxabam (10mg) QD on PostOp Day 1 to 14.
Other Names:
  • Xarelto
Drug: 0.9% Normal Saline
Primary total knee replacement with intravenous normal saline (20 ml) administration before deflation of the tourniquet
Other Names:
  • 0.9% sodium chloride
Drug: 0.9% Normal Saline
Topical 160 ml normal saline application after closure of joint capsule.
Other Names:
  • 0.9% sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of any deep-vein thrombosis, non-fatal pulmonary embolism, or all-cause mortality
Time Frame: within 15 days after surgery (2 days after the last dose of rivaroxaban )
Primary efficacy outcome is the composite of any deep-vein thrombosis, non-fatal pulmonary embolism, or all-cause mortality
within 15 days after surgery (2 days after the last dose of rivaroxaban )
Incidence of major bleeding after the first dose of rivaroxaban and all death related to postoperative bleedings
Time Frame: within 15 days after surgery (2 days after the last dose of rivaroxaban )
Primary safety outcome is the composite of major bleeding after the first dose of rivaroxaban and all death related to postoperative bleedings Major bleeding was defined as bleeding that was fatal, that involved a critical organ, or that required reoperation or clinically overt bleeding outside the surgical site that was associated with a decrease in the hemoglobin level of 2 g or more per deciliter or requiring infusion of 2 or more units of blood
within 15 days after surgery (2 days after the last dose of rivaroxaban )

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of major venous thromboembolism
Time Frame: within 15 days after surgery (2 days after the last dose of rivaroxaban )
the secondary efficacy outcomes include major venous thromboemolism defined as the composite of proximal deep-vein thrombosis, non-fatal pulmonary embolism, and VTE related death
within 15 days after surgery (2 days after the last dose of rivaroxaban )
Secondary safety outcome was composite of any non-major bleeding and all wound complications after operation
Time Frame: within 15 days after surgery (2 days after the last dose of rivaroxaban )
non-major bleeding including hemorrhagic wound complications (excessive wound hematoma or bleeding at the surgical site
within 15 days after surgery (2 days after the last dose of rivaroxaban )
Incidence of wound complications after surgery
Time Frame: within 30 days of the procedure
composite of hematoma, superficial wound infection, and deep infection requiring return to surgery
within 30 days of the procedure
Total blood loss after surgery
Time Frame: From the operation to the postoperative day 4
Total blood loss was calculated according to Nadler et al., which used maximum postoperative reduction of the Hb level adjust for weight and height of the patient. The formula is as follows, Total blood loss = (Total blood volume x [change in Hb level / preoperative Hb level])x1000+volume transfused.
From the operation to the postoperative day 4

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of venographic positive deep-vein thrombosis (any, proximal, distal)
Time Frame: on the second day after last dose of rivaroxaban (postoperative day 15)
on the second day after last dose of rivaroxaban (postoperative day 15)
Incidence of positive finding of pulmonary embolism by computed tomography
Time Frame: on the second day after last dose of rivaroxaban (postoperative day 15)
on the second day after last dose of rivaroxaban (postoperative day 15)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

May 4, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRPG8D1051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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