NCT02094066

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

3 months

First QC Date

March 19, 2014

Last Update Submit

March 24, 2014

Conditions

Hemorrhage

Keywords

tranexamic acidtotal hip arthroplasty

Outcome Measures

Primary Outcomes (1)

  • hemorrhage

    the amount of bleeding in aspirator and sponges

    intraoperative

Secondary Outcomes (1)

  • erythrocyte transfusion

    intraoperative and postoperative 3 days

Study Arms (2)

tranexamic acid

ACTIVE COMPARATOR

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

Drug: tranexamic acid

serum physiologic

SHAM COMPARATOR

preoperative 100 cc serum physiologic

Drug: serum physiologic

Interventions

tranexamic acidDRUG

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

Also known as: lysteda
tranexamic acid
serum physiologicDRUG

preoperative 100 cc ıv serum physiologic

serum physiologic

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes univercity medicine faculty

Kayseri, 38039, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • seher orbay yasli, resident

    Erciyes university medicine faculty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

seher orbay yasli, resident

CONTACT

+905052401933sehersin81@hotmail.com

zeynep tosun, prof

CONTACT

+905326640648zeynep@erciyes.edu.tr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 21, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

March 26, 2014

Record last verified: 2014-03

Locations

TU(1)