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Trial record 21 of 34 for:    "Collagen Disease" | "Tranexamic Acid"

The Blood Saving Effect of Tranexamic Acid in Total Knee Arthroplasty With Rivaroxaban as Thromboprophylaxis

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ClinicalTrials.gov Identifier: NCT02458729
Recruitment Status : Completed
First Posted : June 1, 2015
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):
Wang Jun-Wen, Chang Gung Memorial Hospital

Brief Summary:
The aim of this study was to conduct a prospective, randomized, double-blind study and assess the efficacy of and safety for thromboprophylaxis of rivaroxaban in total knee arthroplasty patients when tranexamic acid is used for bleeding prophylaxis.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: Tranexamic Acid 5%,5ml/amp (intraoperative) Drug: Tranexamic Acid 5%,5ml/amp (3 hours after operation) Drug: 0.9% Normal Saline (intraoperative) Drug: 0.9% Normal Saline (3 hours after operation) Drug: rivaroxaban (10mg) Phase 4

Detailed Description:

Total knee arthroplasty is an effective procedure for end-stage arthritis of the knee in terms of pain relief and functional recovery. However, this procedure is associated with a substantial perioperative blood loss. As high as 69% allogeneic blood transfusion rate was reported in patients receiving total knee arthroplasty when preoperative haemoglabin level was <13 g/dl. Tranexamic acid (TXA), an antifibrinolytic, given intraoperatively, has been reported to be effective in reducing one third of postoperative blood loss in standard total knee arthroplasty. Our previous study showed that TXA reduced total blood loss from 1453mL to 833mL (p<0.001) and the need for transfusion from 20% to 4% (p=0.014) in total knee patients with enoxaparin (Clexane; Glaxo-Smith-Kline, Brentford, United Kindom) for thromboprophylaxis.

In recent years, there have been more effective and practical methods for thrombophylaxis in total hip and knee replacement surgeries. Rivaroxaban is one of the first oral factor Xa inhibitors licensed for this regard. The advantages of rivaroxaban include oral administration, no need to monitor blood levels and no dosing adjustments which are convenient for short hospital stay in contemporary total knee arthroplasty. Its efficacy in preventing venous thromboembolism (VTE) after total knee arthroplasty have been extensitvely investigated in RECORD (Regulation of Coagulation in Orthopaedic surgery to prevent Deep-vein thrombosis and pulmonary embolism) 3 and 4 studies, and the results showed that rivaroxaban 10mg once daily was superior to enoxaparin 40mg subcutaneously once daily or 30mg every 12 hours for 10 to 14 days. Despite of its clinical efficacy in VTE prophylaxis, orthopaedic surgeons are still sceptic in routine use of rivaroxaban in knee and hip surgery and concerned about the increased risk of bleeding complications. A higher reoperation rate regarding wound complications within 30 days of hip and knee replacement in the rivaroxaban group than the tinzaparin group (2.94% versus 1.8%) was reported recently. Similar event has been reported in other studies. However, all these studies did not use TXA as bleeding prophylaxis after hip and knee replacement surgery. The risk of increasing VTE by use of TXA, owing to its antifibrinolytic effects, is the cause of concern.

The aim of this study was to conduct a prospective, randomized, double-blind study and assess the efficacy of and safety for thromboprophylaxis of rivaroxaban in total knee arthroplasty patients when TXA is used for bleeding prophylaxis.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Blood Saving Effect and Wound-related Complications of Tranexamic Acid in Mininally Invasive Total Knee Arthroplasty With Rivaroxaban as Thromboprophylaxis
Study Start Date : August 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Placebo Comparator: Placebo Group
Primary total knee replacement with 0.9% normal saline 20ml administration intravenously twice, five minutes before deflation of the tourniquet and 3 hours after operation Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis
Drug: 0.9% Normal Saline (intraoperative)
0.9% Normal Saline 20ml administered intravenously five minutes before deflation of the tourniquet
Other Name: 0.9% sodium chloride

Drug: 0.9% Normal Saline (3 hours after operation)
0.9% Normal Saline 20ml administered intravenously 3 hours after operation
Other Name: 0.9% Normal Saline

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

Active Comparator: One-dose TXA Group
Primary total knee replacement with 1 g Tranexamic Acid 5%,5ml/amp administrated intravenously five minutes before deflation of the tourniquet. and then 0.9% normal saline 20ml administration intravenously 3 hours after operation Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis
Drug: Tranexamic Acid 5%,5ml/amp (intraoperative)
tranexamic acid 1g administered intravenously five minutes before deflation of the tourniquet
Other Name: Transamine

Drug: 0.9% Normal Saline (3 hours after operation)
0.9% Normal Saline 20ml administered intravenously 3 hours after operation
Other Name: 0.9% Normal Saline

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

Active Comparator: Two-dose TXA Group
Primary total knee replacement with 1 g Tranexamic Acid 5%,5ml/amp administrated intravenously twice, five minutes before deflation of the tourniquet and 3 hours after operation Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14 for VTE prophylaxis
Drug: Tranexamic Acid 5%,5ml/amp (intraoperative)
tranexamic acid 1g administered intravenously five minutes before deflation of the tourniquet
Other Name: Transamine

Drug: Tranexamic Acid 5%,5ml/amp (3 hours after operation)
tranexamic acid 1g administered intravenously 3 hours after operation
Other Name: Transamine

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




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 (POD 15) ]
  2. Incidence of positive finding of pulmonary embolism by computed tomography [ Time Frame: on the second day after last dose of rivaroxaban (POD 15) ]
    In case of suspected pulmonary embolism, computed tomography of the chest was performed



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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): NCT02458729


Locations
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Taiwan
Kaohsiung Chang Gung Memorial Hospital
Koahsiung, Taiwan
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: NCT02458729     History of Changes
Other Study ID Numbers: NMRPG8B6181
First Posted: June 1, 2015    Key Record Dates
Last Update Posted: June 1, 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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Rheumatic Diseases
Tranexamic Acid
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Tranylcypromine
Rivaroxaban
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