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Role of Topical Tranexamic Acid in Total Hip Arthroplasty (TXA)

Primary Purpose

Post Operative Blood Loss

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
Normal Saline Solution
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Blood Loss focused on measuring Blood Loss, Tranexamic Acid, Total Hip Arthroplasty, Post Op, Post Operative, Prevent Post Operative Blood Loss

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-80 years of age.
  • Male or female.
  • Degenerative joint disease of hip joint.
  • Primary uncemented total hip arthroplasty.
  • Willingness to participate in the study, follow up at regular intervals

Exclusion Criteria:

  • Known allergy to tranexamic acid
  • History of any acquired disturbances of color vision
  • Preoperative anemia on basis of pre-operative lab work up (a hemoglobin value of <11 g/dL in females and <12 g/dL in males)
  • History of previous myocardial infarction
  • History of arterial or venous thromboembolic disease
  • History of fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy in the past and/or as identified by a preoperative platelet count of <150,000/mm3, an international normalized ratio of >1.5, or a prolonged partial thromboplastin time
  • Pregnancy (h/o any missed menstrual periods in a women of reproductive age group)
  • Breastfeeding
  • Refusal of blood products
  • Preoperative use of anticoagulant therapy within five days before surgery
  • Medical issues that may pose complications for surgery and would disqualify patient for surgery regardless of clinical trial (e.g. renal and hepatic failure)
  • Major comorbidities (e.g. severe ischemic heart disease )
  • Severe pulmonary disease
  • Preoperative blood donation
  • Participation in another clinical trial involving pharmaceutical drugs

Sites / Locations

  • North Shore Long Island Jewish Lenox Hill Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Group 1

Group 2

Arm Description

Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.

Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline plus 1.5 g (100 mg/mL)Tranexamic Acid is applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.

Outcomes

Primary Outcome Measures

Estimated Blood Loss
Estimated Blood Loss defined as Pre Op Hgb mins the Post Op Day two Hgb.

Secondary Outcome Measures

Mid Thigh Circumference
Measurement of the thigh at the half way point between the prominence of the greater trochanter and the lateral epicondyle of the femur. No data recorded at 2 weeks or 6 weeks for this study population.
Harris Hip Scores
Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.
Harris Hip Scores
Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.
Harris Hip Scores
Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.

Full Information

First Posted
May 29, 2013
Last Updated
February 13, 2018
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT01866943
Brief Title
Role of Topical Tranexamic Acid in Total Hip Arthroplasty
Acronym
TXA
Official Title
Role of Topical Tranexamic Acid in Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Study Start Date
November 2011 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Total hip arthroplasty (THA) is a procedure associated with perioperative blood loss, requiring blood transfusions in some patients. The major cause of this blood loss is due to surgical trauma that induces the clotting cascade and fibrinolysis. Several previous studies and meta-analyses have shown that tranexamic acid is an effective antifibrinolytic agent that reduces blood loss in a variety of situations. Tranexamic acid given in an intravenous form has been extensively studied and shown to be efficacious in cardiothoracic, spine surgical procedures as well as total knee arthroplasty (TKA) and THA. Similarly, topical tranexamic acid has been associated with decreased blood loss in cardiac surgeries as well. Recently, results from a prospective randomized study on the topical use of tranexamic acid in total knee arthroplasty found it to be effective for reducing postoperative blood loss. Taking all of the above into consideration we have proposed a study to evaluate effects of topical application of tranexamic acid on postoperative blood loss and blood transfusion on patients undergoing total hip arthroplasty. The aim of this study is to evaluate the efficacy of the topical application of tranexamic acid on blood loss in patients undergoing a primary unilateral total hip arthroplasty.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Blood Loss
Keywords
Blood Loss, Tranexamic Acid, Total Hip Arthroplasty, Post Op, Post Operative, Prevent Post Operative Blood Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Placebo Comparator
Arm Description
Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline plus 1.5 g (100 mg/mL)Tranexamic Acid is applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed.
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
Tranexamic Acid 1.5 g (100 mg/mL)in 100cc normal saline is applied topically to the wound for 5 minutes time then suctioned and the skin closed. The control group receives just normal saline and no drug.
Intervention Type
Drug
Intervention Name(s)
Normal Saline Solution
Primary Outcome Measure Information:
Title
Estimated Blood Loss
Description
Estimated Blood Loss defined as Pre Op Hgb mins the Post Op Day two Hgb.
Time Frame
Pre Op, Post Op Day 2
Secondary Outcome Measure Information:
Title
Mid Thigh Circumference
Description
Measurement of the thigh at the half way point between the prominence of the greater trochanter and the lateral epicondyle of the femur. No data recorded at 2 weeks or 6 weeks for this study population.
Time Frame
Pre Op
Title
Harris Hip Scores
Description
Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.
Time Frame
Preoperative
Title
Harris Hip Scores
Description
Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.
Time Frame
2 week
Title
Harris Hip Scores
Description
Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.
Time Frame
6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-80 years of age. Male or female. Degenerative joint disease of hip joint. Primary uncemented total hip arthroplasty. Willingness to participate in the study, follow up at regular intervals Exclusion Criteria: Known allergy to tranexamic acid History of any acquired disturbances of color vision Preoperative anemia on basis of pre-operative lab work up (a hemoglobin value of <11 g/dL in females and <12 g/dL in males) History of previous myocardial infarction History of arterial or venous thromboembolic disease History of fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy in the past and/or as identified by a preoperative platelet count of <150,000/mm3, an international normalized ratio of >1.5, or a prolonged partial thromboplastin time Pregnancy (h/o any missed menstrual periods in a women of reproductive age group) Breastfeeding Refusal of blood products Preoperative use of anticoagulant therapy within five days before surgery Medical issues that may pose complications for surgery and would disqualify patient for surgery regardless of clinical trial (e.g. renal and hepatic failure) Major comorbidities (e.g. severe ischemic heart disease ) Severe pulmonary disease Preoperative blood donation Participation in another clinical trial involving pharmaceutical drugs
Facility Information:
Facility Name
North Shore Long Island Jewish Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States

12. IPD Sharing Statement

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Role of Topical Tranexamic Acid in Total Hip Arthroplasty

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