search
Back to results

The Effect of Tranexamic Acid for Total Hip Arthroplasty

Primary Purpose

Hemorrhage

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
tranexamic acid
serum physiologic
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage focused on measuring tranexamic acid, total hip arthroplasty

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erciyes univercity medicine facultyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

tranexamic acid

serum physiologic

Arm Description

preoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes

preoperative 100 cc serum physiologic

Outcomes

Primary Outcome Measures

hemorrhage
the amount of bleeding in aspirator and sponges

Secondary Outcome Measures

erythrocyte transfusion

Full Information

First Posted
March 19, 2014
Last Updated
March 24, 2014
Sponsor
TC Erciyes University
search

1. Study Identification

Unique Protocol Identification Number
NCT02094066
Brief Title
The Effect of Tranexamic Acid for Total Hip Arthroplasty
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 Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage
Keywords
tranexamic acid, total hip arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tranexamic acid
Arm Type
Active Comparator
Arm Description
preoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes
Arm Title
serum physiologic
Arm Type
Sham Comparator
Arm Description
preoperative 100 cc serum physiologic
Intervention Type
Drug
Intervention Name(s)
tranexamic acid
Other Intervention Name(s)
lysteda
Intervention Description
preoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes
Intervention Type
Drug
Intervention Name(s)
serum physiologic
Intervention Description
preoperative 100 cc ıv serum physiologic
Primary Outcome Measure Information:
Title
hemorrhage
Description
the amount of bleeding in aspirator and sponges
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
erythrocyte transfusion
Time Frame
intraoperative and postoperative 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
seher orbay yasli, resident
Phone
+905052401933
Email
sehersin81@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
zeynep tosun, prof
Phone
+905326640648
Email
zeynep@erciyes.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
seher orbay yasli, resident
Organizational Affiliation
Erciyes university medicine faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erciyes univercity medicine faculty
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
seher orbay yasli, resident
Phone
+905052401933
Email
sehersin81@hotmail.com
First Name & Middle Initial & Last Name & Degree
zeynep tosun, prof
Phone
+905326640648
Email
zeynep@erciyes.edu.tr

12. IPD Sharing Statement

Learn more about this trial

The Effect of Tranexamic Acid for Total Hip Arthroplasty

We'll reach out to this number within 24 hrs