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Trial record 30 of 419 for:    TRANEXAMIC ACID

The Use of Tranexamic Acid to Reduce Blood Loss in Acetabular Surgery (TXA)

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ClinicalTrials.gov Identifier: NCT02684851
Recruitment Status : Unknown
Verified October 2016 by Madhav Karunakar, Atrium Health.
Recruitment status was:  Active, not recruiting
First Posted : February 18, 2016
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Madhav Karunakar, Atrium Health

Brief Summary:
The purpose of this study is to determine if patients undergoing acetabular ORIF (open reduction with internal fixation) who receive tranexamic acid have a reduced risk of allogenic blood transfusion, perioperative blood loss, wound complication and higher risk for thromboembolic events compared to patients who receive placebo. Investigators want to determine the cost-effectiveness related to allogenic blood transfusion as a blood loss management strategy in acetabular open reduction internal fixation (ORIF). Orthopaedic surgery carries with it a significant risk for blood loss. Current management of perioperative blood loss is the use of allogenic blood transfusion. Allogenic blood transfusion carries with it a risk for HIV and Hepatitis C as well as multiple adverse reactions. There have been significant efforts to reduce the use of allogenic blood transfusion in orthopaedic surgery. Tranexamic acid, an anti-fibrinolytic agent, has been used in management of blood during surgery. In order to determine the impact of tranexamic acid in reducing blood loss among patients undergoing acetabular ORIF, investigators will conduct a prospective randomized study. Patients undergoing acetabular surgery will be screened for this study. Patients will be then randomized to placebo or tranexamic acid which will be administered during and after surgery. The following data will be collected: patient characteristics, surgery information, blood loss, blood transfusions, wound complication within 30 days of surgery, and cost.

Condition or disease Intervention/treatment Phase
Acetabular Fractures Drug: Tranexamic Acid Drug: Placebo Phase 3

Detailed Description:

In this study, investigators plan to prospectively determine the effect of tranexamic acid on blood loss and outcome after surgery to the acetabulum.

Patients will be randomized into two groups. In this study, investigators plan to administer a 10mg/kg dose within 30 minutes of surgery followed by a 10mg/kg infusion over a 4hr period to the treatment group (for patients weighting over 100kg, a weight of 100kg will be used for the dose calculation). The control group will receive equal volumes of and rates of normal saline.

Research Questions:

  1. Do patients undergoing acetabular ORIF who receive tranexamic acid have a reduced risk of allogenic blood transfusion as compared to patients who receive placebo?
  2. Do patients undergoing acetabular ORIF who receive tranexamic acid have reduced peri-operative blood loss as compared to patients who receive placebo?
  3. Do patients undergoing acetabular ORIF who receive tranexamic acid have a higher risk for thromboembolic events than patients who receive placebo?
  4. Do patients undergoing acetabular ORIF who receive tranexamic acid have a reduced risk of wound complications (prolonged wound drainage, return to the OR within 30 days, infection)?
  5. Is the use of tranexamic acid cost effective relative to the use of allogenic blood transfusion as a blood loss management strategy in acetabular ORIF?

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Tranexamic Acid to Reduce Blood Loss in Acetabular Surgery
Study Start Date : October 2012
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Placebo Comparator: Placebo
Inactive
Drug: Placebo
Placebo

Active Comparator: Tranexamic
Tranexamic acid: anti-fibrinolytic agents
Drug: Tranexamic Acid
Tranexamic acid: anti-fibrinolytic agents
Other Name: Tranexamic acid (anti-fibrinolytic agents )




Primary Outcome Measures :
  1. Allogenic Blood Transfusions [ Time Frame: 30 days ]
    Do patients undergoing acetabular ORIF who receive tranexamic acid have a reduced risk of allogenic blood transfusion as compared to patients who receive placebo?

  2. Peri-operative blood loss [ Time Frame: 30 days ]
    Do patients undergoing acetabular ORIF who receive tranexamic acid have reduced peri-operative blood loss as compared to patients who receive placebo?

  3. Thromboembolic Events [ Time Frame: 30 days ]
    Do patients undergoing acetabular ORIF who receive tranexamic acid have a higher risk for thromboembolic events than patients who receive placebo?

  4. Wound complications [ Time Frame: 30 days ]
    Do patients undergoing acetabular ORIF who receive tranexamic acid have a reduced risk of wound complications (prolonged wound drainage, return to the OR within 30 days, infection)?


Secondary Outcome Measures :
  1. Cost [ Time Frame: 30 days ]
    Is the use of tranexamic acid cost effective relative to the use of allogenic blood transfusion as a blood loss management strategy in acetabular ORIF?



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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:

  • All patients aged 18 or above undergoing acetabular ORIF.

Exclusion Criteria:

  • All patients aged below 18 years undergoing acetabulum surgery
  • Patients with color-blindness (color vision changes used to assess toxicity)
  • Patients with subarachnoid hemorrhage.
  • Patients with active intravascular coagulation.
  • Patients with a previous history of venous thromboembolism or with a history of hypercoaguable conditions (i.e. Factor V Leiden, antiphospholipid antibody).
  • Prisoners
  • Pregnant women

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): NCT02684851


Locations
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United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28205
Sponsors and Collaborators
Atrium Health
Investigators
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Principal Investigator: Madhav Karunakar, MD Atrium Health

Publications:
Haynes RB, et al. Clinical Epidemiology: How to Do Clinical Practice Research. 3rd ed. Lippincott Williams and Wilkins, 2006.
Sadeghi M, Mehr-Aein A. Does a single bolus dose of tranexamic acid reduce blood loss and transfusion requirements during hip fracture surgery? A prospective randomized double blind study in 67 patients. Acta Medica Iranica 2007; 45: 437-42.

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Responsible Party: Madhav Karunakar, Orthopaedic Traumatologist, Atrium Health
ClinicalTrials.gov Identifier: NCT02684851     History of Changes
Other Study ID Numbers: 10-12-06B
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants