The Effect of Tranexamic Acid for Total Hip Arthroplasty

NCT ID: NCT02094066

Last Updated: 2014-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

tranexamic acid

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

Group Type ACTIVE_COMPARATOR

tranexamic acid

Intervention Type DRUG

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

serum physiologic

preoperative 100 cc serum physiologic

Group Type SHAM_COMPARATOR

serum physiologic

Intervention Type DRUG

preoperative 100 cc ıv serum physiologic

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tranexamic acid

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

Intervention Type DRUG

serum physiologic

preoperative 100 cc ıv serum physiologic

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

lysteda

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

seher orbay yasli

resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

seher orbay yasli, resident

Role: PRINCIPAL_INVESTIGATOR

Erciyes university medicine faculty

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Erciyes univercity medicine faculty

Kayseri, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

seher orbay yasli, resident

Role: CONTACT

+905052401933

zeynep tosun, prof

Role: CONTACT

+905326640648

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

seher orbay yasli, resident

Role: primary

+905052401933

zeynep tosun, prof

Role: backup

+905326640648

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2012/683

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Tranexamic Acid Study
NCT00375440 WITHDRAWN NA