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Noninferiority Oral Tranexamic Acid vs Intravenous Administration in Total Hip Arthroplasty

NCT ID: NCT04691362

Last Updated: 2022-12-15

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-14

Brief Summary

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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.

Detailed Description

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Tranexamic acid is an anti-fibrinolytic drug, recommended in total hip arthroplasty to reduce peroperative and postoperative hemorrhagic complications. The original character of our study lies in the serum dosage of tranexamic acid, allowing to correlate the primary objective (blood loss) with this one. The investigators will focus on the reduction of the risks associated with the administration of intravenous medicines, the economic aspect and the ease of use.

Conditions

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Hemorrhage Postoperative Total Blood Loss Arthroplasty Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double blinded randomized controlled trial. Patient, anesthesiologist and surgeon are blinded.

Study Groups

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Oral Tranexamic Acid

128 patients scheduled for primary total hip arthroplasty

Group Type ACTIVE_COMPARATOR

Tranexamic Acid Oral Product

Intervention Type DRUG

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

Intravenous Tranexamic Acid

128 patients scheduled for primary total hip arthroplasty

Group Type ACTIVE_COMPARATOR

Tranexamic acid injection

Intervention Type DRUG

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

Interventions

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Tranexamic Acid Oral Product

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

Intervention Type DRUG

Tranexamic acid injection

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Jean François Brichant

Head of Anesthesiology Departement

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHU de Liège

Liège, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 30640647 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30312799 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38214552 (View on PubMed)

Other Identifiers

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2020-316

Identifier Type: -

Identifier Source: org_study_id