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Serial Use of Intravenous and Oral Tranexamic Acid in Primary Total Knee Arthroplasty Patients

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ClinicalTrials.gov Identifier: NCT03109652
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Seung-Baik Kang, Seoul National University Hospital

Brief Summary:
The usefulness of tranexamic acid(TXA) to reduce blood loss and transfusion in total knee replacement arthroplasty(TKRA) has been demonstrated. However, the optimal does, duration of treatment and route of administration of TXA to reduce blood loss while minimizing adverse effects remain uncertain. Recently, the serial use of perioperative IV and post-operative oral TXA has been shown to significantly reduce transfusion rate without increasing thromboembolic complications compared to placebo. The aim of this study is to 1) determine the beneficial effect and safety of the serial treatment of IV and oral TXA over IV use alone and 2) assess the sufficient length of postoperative use of oral TXA in TKRA patients.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Tranexamic Acid Phase 4

Detailed Description:

It has been demonstrated that tranexamic acid (TXA) reduces the peri-operative blood loss as well as the need for transfusion in total knee replacement arthroplasty(TKRA). The anti-fibrinolytic effects of TXA have been shown to mainly present in the wound that, in previous studies, the use of TXA decreased the blood loss without increasing the risk of thromboembolic complications. Nevertheless, the optimal dose, duration of treatment and route of administration of TXA to reduce blood loss while minimizing adverse effects remain uncertain.

To use TXA as a pharmacologic alternative to transfusion, optimal regimen should be elucidated. Various studies have reported the effect of perioperative use of intravenous or topical TXA. Meta-analyses concluded that combined use of intravenous and topical TXA is more effective in reducing the blood loss and transfusion rate without increasing the risk of deep vein thrombosis or pulmonary embolism compared to the use of either intravenous TXA or topical TXA alone. Both intravenous and topical administration was conducted pre or intraoperatively or within 6 hours post-operatively mainly due to conceivable risk of thromboembolic event when TXA is used continuously after surgery. However, regarding the fact that systemic activation of fibrinolysis starts post-operatively in TKRA using tourniquets and lasts over 18 hours, the continuous use of TXA after surgery might have additional benefit over the single day use. Moreover, the serial use of post-operative oral TXA for 5 days after perioperative IV TXA use has been shown to significantly reduce transfusion rate without increasing thromboembolic complications compared to placebo.

Therefore, in this study, the investigators aimed to 1) investigate the effect of serial use of perioperative IV and post-operative oral TXA in reducing the blood loss and transfusion risk compared to single day perioperative use of IV TXA and 2) assess the sufficient length of postoperative use of oral TXA in TKRA patients.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Serial Use of Intravenous and Oral Tranexamic Acid in Primary Total Knee Arthroplasty Patients: A Randomized Controlled Study
Actual Study Start Date : July 10, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: IV TXA alone
One ampule of 500mg/ml tranexamic acid(TXA) inj is injected intravenously during operation after box cutting procedure(before tourniquet deflation). Additionally, 1 ampule of TXA is administrated 3 hours after first injection on the day of operation.
Drug: Tranexamic Acid
On the day of operation, same dose of IV tranexamic acid(TXA) is given to all subjects in three study groups. Oral TXA is given from postoperative day 1 only to experimental groups. Duration of oral TXA administration is different between two experimental groups. (5 days in "IV TXA and Oral TXA 5 days group" and 2 days in "IV TXA and Oral TXA 2 days group")

Experimental: IV TXA and Oral TXA 5 days

One ampule of 500mg/ml tranexamic acid(TXA) inj is injected intravenously during operation after box cutting procedure(before tourniquet deflation). Additionally, 1 ampule of TXA is administrated 3 hours after first injection on the day of operation.

Two 250mg capsules of oral TXA(Transamin Cap) is given three times a day, 30 minutes after each meal, from postoperative day 1 to day 5.

Drug: Tranexamic Acid
On the day of operation, same dose of IV tranexamic acid(TXA) is given to all subjects in three study groups. Oral TXA is given from postoperative day 1 only to experimental groups. Duration of oral TXA administration is different between two experimental groups. (5 days in "IV TXA and Oral TXA 5 days group" and 2 days in "IV TXA and Oral TXA 2 days group")

Experimental: IV TXA and Oral TXA 2 days

One ampule of 500mg/ml tranexamic acid(TXA) inj is injected intravenously during operation after box cutting procedure(before tourniquet deflation). Additionally, 1 ampule of TXA is administrated 3 hours after first injection on the day of operation.

Two 250mg capsules of oral TXA(Transamin Cap) is given three times a day, 30 minutes after each meal, from postoperative day 1 to day 2.

Drug: Tranexamic Acid
On the day of operation, same dose of IV tranexamic acid(TXA) is given to all subjects in three study groups. Oral TXA is given from postoperative day 1 only to experimental groups. Duration of oral TXA administration is different between two experimental groups. (5 days in "IV TXA and Oral TXA 5 days group" and 2 days in "IV TXA and Oral TXA 2 days group")




Primary Outcome Measures :
  1. Change from preoperative hemoglobin at day 2 [ Time Frame: Preop. day 1 to postop. day 2 ]
    Hemoglobin (g/dL)

  2. Change from preoperative hemoglobin at day 6 [ Time Frame: Preop. day 1 to postop. day 6 ]
    Hemoglobin (g/dL)


Secondary Outcome Measures :
  1. Transfusion rate and amount [ Time Frame: Postoperative day 0 to day 6 ]
    transfusion trigger: packed red blood cell(RBC) 1 pack is given if Hb < 7 or 7 ≤ Hb< 8 with symptom of anemia

  2. Complications [ Time Frame: up to 6 week after operation ]
    CT angiography on postoperative day 6 for evaluation of deep vein thrombosis, Pulmonary embolism, superficial or deep infection, and other complications are assessed clinically.

  3. Calculated Blood loss [ Time Frame: Postop. day 6 ]
    Based on predicted blood volume and hemoglobin balance



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Candidate for total knee replacement arthroplasty due to osteoarthritis of the knee.

Exclusion Criteria:

  • Known allergic reaction to tranexamic acid
  • Secondary arthritis (ex. Rheumatic arthritis, traumatic arthritis, septic arthritis)
  • History of thromboembolic event including deep vein thrombosis, pulmonary embolism, cerebral infarction, transient ischemic attack, myocardial infarction, angina
  • Premenopausal female
  • Known congenital or acquired coagulopathy
  • Currently in treatment with Adenosine disphosphate receptor inhibitors, Vitamin K antagonist, Factor Xa inhibitor, Direct thrombin inhibitor or Heparin
  • Aspirin administration within 5 days before operation
  • Preoperative Prothrombin time(PT) international normalized ratio(INR) > 1.4
  • Severe systemic comorbidities of American Society of Anesthesiology (ASA) grade 4 including heart failure, renal failure, hepatic failure, pulmonary disease and cancer
  • Do not agree to participate in the study

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): NCT03109652


Contacts
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Contact: Seung-Baik Kang, MD, PhD +82-870-3931 ossbkang@gmail.com
Contact: Chan Yoon, MD +82-870-2316 yoon.chan.alex@gmail.com

Locations
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Korea, Republic of
Seoul National University Boramae Medical Center Recruiting
Seoul, Dongjak Gu, Korea, Republic of, 07061
Contact: Seung-Baik Kang, MD, PhD    +82-2-870-3931    ossbkang@gmail.com   
Contact: Chan Yoon, MD    +82-2-870-2316    yoon.chan.alex@gmail.com   
Principal Investigator: Seung-Baik Kang, MD, PhD         
Principal Investigator: Chong Bum Chang, MD, PhD         
Principal Investigator: Moon Jong Chang, MD, PhD         
Principal Investigator: Chan Yoon, MD         
Principal Investigator: Min Kyu Song, MD         
Principal Investigator: Jae-Hoon Shin, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Seung-Baik Kang, MD, PhD SMG-SNU Boramae Medical Center

Publications:

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Responsible Party: Seung-Baik Kang, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03109652     History of Changes
Other Study ID Numbers: SNUBMC_2017001
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Seung-Baik Kang, Seoul National University Hospital:
total knee replacement arthroplasty
total knee arthroplasty
tranexamic acid
oral tranexamic acid
transfusion
blood loss
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants