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Trial record 48 of 419 for:    TRANEXAMIC ACID

Study Comparing Topical Versus Intravenous Tranexamic Acid in Anterior Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT03359525
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Samik Banerjee, Albany Medical College

Brief Summary:
Brief Summary Title: Prospective Randomized Trial Comparing Topical Versus Intravenous Tranexamic Acid (TXA) in Anterior (Total hip arthroplasty) Several strategies have been used to reduce transfusion requirements during total hip arthroplasty (THA). Recently, anti-fibrinolytic agent TXA, has been used extensively in THAs to minimize intra-operative blood losses. However, few studies have compared the efficacy of topical versus intravenous use in direct anterior THA. Therefore, the investigators will attempt to evaluate differences in the post-operative outcomes of topical versus intravenous TXA in Direct anterior approach to THA. The investigators propose to conduct a prospective randomized study in which patients who have exhausted non-operative treatment for hip osteoarthritis and are opting for THA will be randomized into 3 groups in a 1:1:1 ratio based on a computer generated algorithm following inclusion and exclusion criteria as described below. Patients will be distributed in to 3 groups as follows: Group A: Intravenous TXA at a dose of 1 gram administered 30 min prior to skin incision and 1 gram 3 hours after the procedure. (Total dose: 2 grams) Group B: Topical TXA at a dose of 1 gram injected in to the peri-articular tissues prior to closure and 1 gram injected into the joint through the drain following wound closure. (Total dose:2 grams) Group C: Combined Intravenous 1 gram given intravenous 30 min prior to skin incision and topical TXA (1 gram) injected into the peri-articular tissues prior to closure. (Total dose: 2 grams). The number of subjects needed to achieve 90% power was calculated based on a one-way fixed effects analysis of variance with 3 levels. Primary endpoint used was drainage measured in milliliters in the post-operative (POD) #1 following surgery. Criterion for significance (alpha) was set at 0.05 and the ANOVA statistics was non-directional (two tailed). Preliminary data indicated that drainage volume averages 250 ml with a standard deviation of 160 ml in our operating room. Difference (maximum to minimum of the three levels) of 150 ml was judged to be the minimally clinically relevant difference in drainage volume (effect size =0.38). A 20% loss to follow up was also assumed. The study will need 38 cases per cell for a total of 114 cases to achieve 90% power of detecting a difference this large. Data metrics will be tabulated into excel spreadsheets. Data analysis will be performed using statistical software. Quantitative data will be analyzed using non-directional analysis of variance (ANOVA) with Tukey's test for multiple comparisons. Non-normality or heteroscedasticity of data will either be corrected by transformation or a non-parametric (Kruskal Wallis) test will be used. Categorical data will be analyzed using chi-square tests (or Fisher's exact test if any cells expected value is 5 or less). A p-value <0.05 will be considered statistically significant.

Condition or disease Intervention/treatment Phase
Tranexamic Acid Adverse Reaction Drug: Tranexamic Acid Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Prospective Randomized Study Comparing Topical Versus Intravenous Tranexamic Acid in Anterior Total Hip Arthroplasty
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
Group A: Intravenous Tranexamic acid at a dose of 1 gram administered 30 min prior to skin incision and 1 gram 3 hours after the procedure. (Total dose administered is 2 grams)
Drug: Tranexamic Acid
intravenous versus Intraarticular versus intravenous

Experimental: Group B
Group B: Topical Tranexamic acid at a dose of 1 gram injected in to the periarticular tissues prior to closure and 1 gram injected into the joint through the drain following wound closure. (Total dose administered is 2 grams)
Drug: Tranexamic Acid
intravenous versus Intraarticular versus intravenous

Experimental: Group C
Group C: Combined Intravenous 1 gram given intravenous 30 min prior to skin incision and topical tranexamic acid (1 gram) injected in to the periarticular tissues prior to closure. (Total dose administered is 2 grams)
Drug: Tranexamic Acid
intravenous versus Intraarticular versus intravenous




Primary Outcome Measures :
  1. Post-operative drain output [ Time Frame: Drain output will be measured in milliliters on Post-operative Day 1 following total hip arthroplasty . This will be a one time measurement for every participant enrolled in the study. ]
    This will be measured from the drain output recorded over 24 hours on Post-operative day 1. This is a one time measurement for every participant enrolled in to the study.


Secondary Outcome Measures :
  1. Change in post operative hemoglobin [ Time Frame: Post-operative day 1 and day 2 hemoglobin change compared to pre-operative hemoglobin. ]
    calculated from change in pre-op and post operative hemoglobin measured in g/dl. There will be 2 recordings for every participant enrolled in the study for the entire study period.

  2. Allogeneic blood transfusion rates [ Time Frame: Measured in the number of participants had transfusion during first week following total hip arthroplasty ]
    Measured in the number of participants who received a blood transfusion during the hospital stay following total hip arthroplasty

  3. Readmissions [ Time Frame: Number of readmissions and emergency department visits measured in number of patients who were readmitted or visited the emergency department during first 90 days after surgery. ]
    Number of times participants were admitted after the surgery within 90 days after surgery

  4. Length of stay [ Time Frame: Measured in number of days patient stayed in the hospital following total hip arthroplasty. This will be one measurement for each participant in the study within 1 week after surgery. ]
    Number of days the patient spent in the hospital after total hip arthroplasty

  5. DVT [ Time Frame: Incidence of deep vein thrombosis measured in number of patients having this complication during first 90 days after surgery ]
    Incidence of DVT among participants enrolled in the study occurring with 90 days of surgery.

  6. Wound infection [ Time Frame: Wound infection rates measured in number of cases occuring within first 90 days after total hip arthroplasty. ]
    Incidence of superficial and deep wound infection among participants enrolled in the study

  7. Emergency department visits [ Time Frame: Number of times participants visited the emergency department after discharge from the hospital within 90 days after total hip arthroplasty ]
    Number of times participants visited the emergency department after discharge from the hospital within 90 days after total hip arthroplasty

  8. Pulmonary Thromboembolism [ Time Frame: Incidence of Pulmonary thromboembolism measured in number of patients having this complication during first 90 days after surgery ]
    Incidence of Pulmonary thromboembolism among participants enrolled in the study occurring with 90 days of surgery.

  9. Number of units of blood transfused [ Time Frame: Measured in the number of units of blood transfusion the participants received during the first week following total hip arthroplasty. ]
    Measured in the number of units of blood transfusion each participant received a blood transfusion during their hospital stay following total hip arthroplasty.

  10. Change in post operative hematocrit compared to pre-operative hematocrit [ Time Frame: Post-operative day 1 and day 2 hematocrit change compared to pre-operative hematocrit. ]
    calculated from change in pre-op and post op hematocrit measured in percentage. There will be 2 recordings for every participant enrolled in the study for the entire study period.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

To be eligible to participate in the study, subjects must meet the following criteria:

  1. Males or females age > 18 years and <80 years
  2. Informed consent
  3. Diagnosis of primary osteoarthritis or osteonecrosis
  4. Previous history of contralateral hip or knee arthroplasty will not be excluded from the study Exclusion criteria

Subjects who meet any of the following criteria will NOT be eligible to participate in the study:

  1. Unable to comply with study requirements i.e unable to complete first follow-up visit at 4 weeks or if they are unable to follow-up.
  2. Has an active joint infection\
  3. Immuno-suppression, e.g., human immunodeficiency virus (HIV) infection, s/p organ transplantation, receipt of steroids for > 10 days at > 10 mg of prednisone equivalent daily within the 90 days prior to enrollment
  4. Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  5. Body mass index > 45
  6. Life expectancy < 6 months
  7. Renal insufficiency (serum creatinine >2.5 mg/dl)
  8. Pre-operative Hemoglobin <8 gm/dl
  9. Congenital and acquired coagulopathy
  10. Patients on pre-operative therapeutic anticoagulation
  11. Patients who need post-operative therapeutic anticoagulation
  12. Pregnancy and nursing mothers or women who are expected to nurse their babies within one month of surgery
  13. History of thromboembolism, stroke, transient ischemic attack, traumatic brain injury, subdural, or subarachnoid hemorrhage
  14. History of reported allergy to tranexamic acid
  15. Uncontrolled Hypertension
  16. Non-steroidal antiinflammatory use within 3 weeks of surgery other than Celebrex.
  17. Patients who continue the use of aspirin and have not stopped for more than 7 days prior to surgery.
  18. Patients who need to be on any anticoagulation other than aspirin 325 mg BID will be excluded from the study.
  19. Prisoners will be excluded from the study.
  20. Patients with history of acquired defective color vision
  21. Plan for staged bilateral total hip procedures within 14 days
  22. Family history of thromboembolism
  23. Patient unable to receive spinal anesthesia

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): NCT03359525


Contacts
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Contact: Samik Banerjee, MBBS 908-376-8990 banerjs1@mail.amc.edu

Locations
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United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Samik Banerjee, MBBS         
Contact: Ravneet Bhullar, MD       bhullar@amc.edu   
Sponsors and Collaborators
Albany Medical College
Investigators
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Principal Investigator: Ravneet S Bhullar, MD Albany Medcial Center

Publications of Results:

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Responsible Party: Samik Banerjee, Principal Investigator, Division of Orthopaedic Surgery, Albany Medical College
ClinicalTrials.gov Identifier: NCT03359525     History of Changes
Other Study ID Numbers: 4744
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants