NCT01940692

Brief 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
  • The rate of perioperative and postoperative blood transfusion
  • The number of blood units transfused
  • The length of hospital stay
  • Perioperative given intravenous isotonic fluid

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 28, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 12, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 5, 2016

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

August 28, 2013

Last Update Submit

February 4, 2016

Conditions

Osteoarthrosis

Outcome Measures

Primary Outcomes (1)

  • Postoperative Bloodloss

    Measured with a simple blood sample on day one after surgery

    Day 1 after surgery

Secondary Outcomes (5)

  • Rate of perioperative and postoperative blood transfusion

    Patients will be followed for the duration of hospital stay, an expected average of 5 days

  • Number of blood units transfused

    Patients will be followed for the duration of hospital stay, an expected average of 5 days

  • Length of hospital stay

    Measured when patient goes home, minimum 5 days after surgery

  • Severity of pain at rest as determined with use of a visual analog scale

    Patients will be followed for the duration of hospital stay, an expected average of 5 days

  • Perioperatively given intravenous isotonic fluid

    Patients will be followed for the duration of hospital stay, an expected average of 5 days

Other Outcomes (1)

  • Preoperative hemoglobin level

    The day before the surgery

Study Arms (2)

Intravenous tranexamic acid

ACTIVE COMPARATOR

Will receive 1.5g intravenous tranexamic acid preoperatively

Drug: 1.5g intravenous Exacyl

Intra-articular tranexamic acid

EXPERIMENTAL

Will receive 3g intra-articular tranexamic acid after wound closing

Drug: 3.0g intra-articular Exacyl

Interventions

1.5g intravenous ExacylDRUG

intravenous administration of 1.5g Exacyl preoperatively

Intravenous tranexamic acid
3.0g intra-articular ExacylDRUG

3g Intra-articular Exacyl administration postoperatively

Intra-articular tranexamic acid

Eligibility Criteria

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

You may not qualify if:

  • History of coagulopathy
  • Allergy to tranexamic acid
  • preoperative anemia
  • fibrinolytic disorders
  • history of arterial or venous thromboembolic disease
  • disturbances of color vision
  • pregnancy
  • breastfeeding
  • major comorbidities
  • participation in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Related Publications (1)

  • Vles GF, Corten K, Driesen R, van Elst C, Ghijselings SG. Hidden blood loss in direct anterior total hip arthroplasty: a prospective, double blind, randomized controlled trial on topical versus intravenous tranexamic acid. Musculoskelet Surg. 2021 Dec;105(3):267-273. doi: 10.1007/s12306-020-00652-0. Epub 2020 Mar 10.

    PMID: 32152813DERIVED

Related Links

MeSH Terms

Conditions

Osteoarthritis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Kristoff Corten, Prof. dr.

    Ziekenhuis Oost-Limburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical student

Study Record Dates

First Submitted

August 28, 2013

First Posted

September 12, 2013

Study Start

July 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

February 5, 2016

Record last verified: 2016-02

Locations

BE(1)