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Topical and Intravenous Administration of TXA Are Equally Effective in DAA THA

NCT01940692 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-02-05

No results posted yet for this study

Summary

Through a randomized controlled trial, we will compare the intravenous administration of tranexamic acid with the intra-articular application after a total hip arthroplasty through direct anterior approach.

* RCT, prospective study
* Academic-monocentric study
* Clinical outcome measurements The postoperative blood loss will be the primary outcome. Secondary outcomes are

1. The rate of perioperative and postoperative blood transfusion
2. The number of blood units transfused
3. The length of hospital stay
4. Perioperative given intravenous isotonic fluid

The Null-hypothesis is that there is no significant difference in postoperative blood loss between intra-articular and intravenous administration of TXA.

Conditions

  • Osteoarthrosis

Interventions

DRUG

1.5g intravenous Exacyl

intravenous administration of 1.5g Exacyl preoperatively

DRUG

3.0g intra-articular Exacyl

3g Intra-articular Exacyl administration postoperatively

Sponsors & Collaborators

  • Ziekenhuis Oost-Limburg

    lead OTHER

Principal Investigators

  • Kristoff Corten, Prof. dr. · Ziekenhuis Oost-Limburg

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01940692 on ClinicalTrials.gov