Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

The Effect of Tranexamic Acid for Total Hip Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 19, 2014
First Posted Date  ICMJE March 21, 2014
Last Update Posted Date March 26, 2014
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2014)
hemorrhage [ Time Frame: intraoperative ]
the amount of bleeding in aspirator and sponges
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02094066 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2014)
erythrocyte transfusion [ Time Frame: intraoperative and postoperative 3 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Tranexamic Acid for Total Hip Arthroplasty
Official Title  ICMJE The Effects of High Doze Tranexamic Acid Application on Hemorrhage, Blood Transfusion, Fibrin Degradation Products, and Kidney Functions for Total Hip Arthroplasty
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hemorrhage
Intervention  ICMJE
  • Drug: tranexamic acid
    preoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes
    Other Name: lysteda
  • Drug: serum physiologic
    preoperative 100 cc ıv serum physiologic
Study Arms  ICMJE
  • Active Comparator: tranexamic acid
    preoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes
    Intervention: Drug: tranexamic acid
  • Sham Comparator: serum physiologic
    preoperative 100 cc serum physiologic
    Intervention: Drug: serum physiologic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 20, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2014
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02094066
Other Study ID Numbers  ICMJE 2012/683
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party seher orbay yasli, TC Erciyes University
Study Sponsor  ICMJE TC Erciyes University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: seher orbay yasli, resident Erciyes university medicine faculty
PRS Account TC Erciyes University
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP