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Comparison of Topical and Infusion Tranexamic Acid After Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT02453802
Recruitment Status : Unknown
Verified May 2015 by Wang Jun-Wen, Chang Gung Memorial Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 27, 2015
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Wang Jun-Wen, Chang Gung Memorial Hospital

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Tranexamic Acid 5%,5ml/amp Drug: rivaroxaban (10mg) Drug: 0.9% Normal Saline Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Topical and Infusion Tranexamic Acid on Blood Loss and Risk of Deep Vein Thrombosis After Total Knee Arthroplasty
Study Start Date : June 2015
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


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 Name: Transamine

Drug: rivaroxaban (10mg)
Oral rivaroxabam (10mg) QD on PostOp Day 1 to 14.
Other Name: Xarelto

Drug: 0.9% Normal Saline
Primary total knee replacement with intravenous normal saline (20 ml) administration before deflation of the tourniquet
Other Name: 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
IV TXA group: Primary total knee replacement with 1 g tranexamic acid administrated intravenously before deflection of the tourniquet
Other Name: Transamine

Drug: rivaroxaban (10mg)
Oral rivaroxabam (10mg) QD on PostOp Day 1 to 14.
Other Name: Xarelto

Drug: 0.9% Normal Saline
Topical 160 ml normal saline application after closure of joint capsule.
Other Name: 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 Name: Xarelto

Drug: 0.9% Normal Saline
Primary total knee replacement with intravenous normal saline (20 ml) administration before deflation of the tourniquet
Other Name: 0.9% sodium chloride

Drug: 0.9% Normal Saline
Topical 160 ml normal saline application after closure of joint capsule.
Other Name: 0.9% sodium chloride




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.


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


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453802


Contacts
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Contact: Jun-Wen Wang, MD 886-7-7317123 wangjw@adm.cgmh.org.tw

Locations
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Taiwan
Kaohsiung Chang Gung Memorial Hospital Not yet recruiting
Koahsiung, Taiwan
Contact: Jun-Wen Wang, MD    886-7-7317123    wangjw@adm.cgmh.org.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Chair: Jun-Wen Wang, MD Chang Gung Memorial Hospital

Publications:

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Responsible Party: Wang Jun-Wen, Clinical Professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02453802     History of Changes
Other Study ID Numbers: CMRPG8D1051
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Keywords provided by Wang Jun-Wen, Chang Gung Memorial Hospital:
Tranexamic Acid
Total Knee Arthroplasty
Rivaroxaban
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Tranylcypromine
Rivaroxaban
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anticoagulants
Antidepressive Agents
Psychotropic Drugs
Monoamine Oxidase Inhibitors
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs