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The Effect of Tranexamic Acid for Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT02094066
Recruitment Status : Unknown
Verified March 2014 by seher orbay yasli, TC Erciyes University.
Recruitment status was:  Recruiting
First Posted : March 21, 2014
Last Update Posted : March 26, 2014
Sponsor:
Information provided by (Responsible Party):
seher orbay yasli, TC Erciyes University

Brief Summary:
The aim of this study is to investigate the effects of tranexamic acid on hemorrhage, blood transfusion, fibrin degradation products and kidney functions for total hip arthroplasty.

Condition or disease Intervention/treatment Phase
Hemorrhage Drug: tranexamic acid Drug: serum physiologic Phase 4

Detailed Description:
Orthopedic surgery may be associated with substantial blood loss requiring transfusion of erythrocytes.Transfusion of allogeneic erythrocytes is not free of adverse events and has been associated with transmission of infectious diseases, increased postoperative bacterial infection, immune sensitization, and transfusion related acute lung injury. Measures taken to allay concerns about the safety of blood transfusions have translated into the increasing cost of allogeneic blood units. Blood banks regularly undergo blood shortages. For these reasons, there is a need to reduce allogeneic blood transfusions. A number of effective interventions have been developed, such as preoperative autologous donation, cell salvage, or the use of erythropoietin. Pharmacologic agents such as aprotinin, tranexamic acid, or epsilon-aminocaproic acid (EACA) could reduce perioperative blood loss by interfering with fibrinolysis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of High Doze Tranexamic Acid Application on Hemorrhage, Blood Transfusion, Fibrin Degradation Products, and Kidney Functions for Total Hip Arthroplasty
Study Start Date : March 2014
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: tranexamic acid
preoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes
Drug: tranexamic acid
preoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes
Other Name: lysteda

Sham Comparator: serum physiologic
preoperative 100 cc serum physiologic
Drug: serum physiologic
preoperative 100 cc ıv serum physiologic




Primary Outcome Measures :
  1. hemorrhage [ Time Frame: intraoperative ]
    the amount of bleeding in aspirator and sponges


Secondary Outcome Measures :
  1. erythrocyte transfusion [ Time Frame: intraoperative and postoperative 3 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA 2-3
  • 18-75 age
  • total hip arthroplasty surgery
  • regional anesthesia

Exclusion Criteria:

  • allergies to drug
  • liver and kidney failure
  • ischemic heart disease
  • coagulopathy

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): NCT02094066


Contacts
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Contact: seher orbay yasli, resident +905052401933 sehersin81@hotmail.com
Contact: zeynep tosun, prof +905326640648 zeynep@erciyes.edu.tr

Locations
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Turkey
Erciyes univercity medicine faculty Recruiting
Kayseri, Turkey, 38039
Contact: seher orbay yasli, resident    +905052401933    sehersin81@hotmail.com   
Contact: zeynep tosun, prof    +905326640648    zeynep@erciyes.edu.tr   
Sponsors and Collaborators
TC Erciyes University
Investigators
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Principal Investigator: seher orbay yasli, resident Erciyes university medicine faculty

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Responsible Party: seher orbay yasli, resident, TC Erciyes University
ClinicalTrials.gov Identifier: NCT02094066     History of Changes
Other Study ID Numbers: 2012/683
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014
Keywords provided by seher orbay yasli, TC Erciyes University:
tranexamic acid
total hip arthroplasty
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants