NCT04691362

Brief Summary

To find noninferiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss and serum concentration during primary total hip arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2021

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

December 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2022

Completed
Last Updated

December 15, 2022

Status Verified

December 1, 2022

Enrollment Period

2 years

First QC Date

December 29, 2020

Last Update Submit

December 14, 2022

Conditions

Hemorrhage PostoperativeTotal Blood LossArthroplasty Complications

Outcome Measures

Primary Outcomes (1)

  • Total blood loss

    Peroperative (suction) and postoperative (drainage) total blood loss

    First 48 hours after surgery

Secondary Outcomes (9)

  • Serum concentration of tranexamic acid

    2 hours after oral administration

  • Serum concentration of tranexamic acid

    6 hours after oral administration

  • Serum concentration of tranexamic acid

    30 minutes after intravenous administration

  • Serum concentration of tranexamic acid

    4 hours after intravenous administration

  • Serum hemoglobin variation

    24 hours after surgery

  • +4 more secondary outcomes

Study Arms (2)

Oral Tranexamic Acid

ACTIVE COMPARATOR

128 patients scheduled for primary total hip arthroplasty

Drug: Tranexamic Acid Oral Product

Intravenous Tranexamic Acid

ACTIVE COMPARATOR

128 patients scheduled for primary total hip arthroplasty

Drug: Tranexamic acid injection

Interventions

Tranexamic Acid Oral ProductDRUG

Oral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration

Oral Tranexamic Acid
Tranexamic acid injectionDRUG

Intravenous administration of 1 gramme tranexamic acid 30 minutes before skin incision and 1 gramme intravenous tranexamic acid 4 hours after first administration

Intravenous Tranexamic Acid

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- ASA physical status 1, 2 and 3 scheduled for primary total hip arthroplasty

You may not qualify if:

  • Renal failure with serum creatinine level higher than 1,40 mg/dL
  • Thromboembolic events in last 12 months before surgery
  • Pregnancy
  • Congenital or acquired coagulation diseases
  • History of gastric surgery that could lead to malabsorption
  • Diabetic gastro-paresis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Liège

Liège, 4000, Belgium

Location

Related Publications (3)

  • Fillingham YA, Ramkumar DB, Jevsevar DS, Yates AJ, Bini SA, Clarke HD, Schemitsch E, Johnson RL, Memtsoudis SG, Sayeed SA, Sah AP, Della Valle CJ. Tranexamic acid in total joint arthroplasty: the endorsed clinical practice guides of the American Association of Hip and Knee Surgeons, American Society of Regional Anesthesia and Pain Medicine, American Academy of Orthopaedic Surgeons, Hip Society, and Knee Society. Reg Anesth Pain Med. 2019 Jan;44(1):7-11. doi: 10.1136/rapm-2018-000024. No abstract available.

    PMID: 30640647BACKGROUND

  • Wu Y, Zeng Y, Hu Q, Li M, Bao X, Zhong J, Shen B. Blood loss and cost-effectiveness of oral vs intravenous tranexamic acid in primary total hip arthroplasty: A randomized clinical trial. Thromb Res. 2018 Nov;171:143-148. doi: 10.1016/j.thromres.2018.10.006. Epub 2018 Oct 6.

    PMID: 30312799BACKGROUND

  • Piette N, Beck F, Carella M, Hans G, Maesen D, Kurth W, Lecoq JP, Bonhomme VL. Oral as compared to intravenous tranexamic acid to limit peri-operative blood loss associated with primary total hip arthroplasty: A randomised noninferiority trial. Eur J Anaesthesiol. 2024 Mar 1;41(3):217-225. doi: 10.1097/EJA.0000000000001950. Epub 2024 Jan 12.

    PMID: 38214552DERIVED

MeSH Terms

Conditions

Postoperative HemorrhageExsanguination

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blinded randomized controlled trial. Patient, anesthesiologist and surgeon are blinded.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesiology Departement

Study Record Dates

First Submitted

December 29, 2020

First Posted

December 31, 2020

Study Start

January 1, 2021

Primary Completion

December 14, 2022

Study Completion

December 14, 2022

Last Updated

December 15, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)