Etude de dose de l’acide tranexamique dans la prothèse totale de hanche pour réduire la perte d’hémoglobine post-opératoire. Etude de phase 2 randomisée en double aveugle monocentrique. Etude PRADO

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Saint Etienne

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

6 Dec 2023 → 11 Jul 2025

Decision date (initial)

2023-04-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

University hospital center of SAINT-ETIENNE

External identifiers

EU CT number

2022-502532-38-01

ClinicalTrials.gov

NCT03822793

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To evaluate of the dose-response relationship of intravenous intravenous tranexamic acid administration in the total hip prosthesis on the
reduction of perioperative hemoglobin loss.

Secondary objectives 6

1. To evaluate the dose-concentration-response relationship (pharmacokinetic-pharmacodynamic)
2. To compare erythrocyte transfusion in patient groups between D1 (day of surgery) and D8.
3. To compare the proportion of patients with anemia less than 10 g / dl between patient groups between D1 and D8.
4. To compare the occurrence of a symptomatic thromboembolic event, a convulsive seizure or a death until D8 between the groups.
5. Measure, at D45 ± 1 week, the rate of complications such as: venous/arterial thromboembolism, presence of hematoma requiring repeat surgery or associated with infection.
6. Explore the consistency and extent of the dose-response effect of tranexamic acid during the first postoperative week

Conditions and MedDRA coding

Arthropathy of Hip

Study design 1 period

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Patient requiring primary hip arthroplasty (less than 3 months)
2. Consent of the patient or a family member or the support person

Exclusion criteria 6

1. Contraindication to tranexamic acid
2. Contraindication to apixaban
3. Pregnancy
4. Patient receiving a curative anticoagulating treatment in the preoperative period
5. Bilateral or previous hip arthroplasty
6. Hemorrhagic surgery less than 2 weeks old

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of haemoglobin decrease in the perioperative period. It requires the sampling of haemoglobin before surgery and on the fourth postoperative day.

Secondary endpoints 7

1. For tranexamic acid pharmacokinetics, the outcome measure is the sampling of tranexamic blood concentration.
2. For tranexamic acid pharmacodynamics, the outcome is the sampling of D-Dimer levels.
3. For allogenic red blood cell transfusion, the outcome measure will be the percentage of patients that will receive the transfusion of at least one allogenic red blood cell unit in the perioperative period.
4. For severe anaemia (defined as a level of haemoglobin <10 gram by deciliter), the outcome measure will be the percentage of patients that will have at least one value of haemoglobin <10 gram by deciliter in the perioperative period.
5. For the incidence of symptomatic thrombotic events and death, the outcome measure is a combined criteria of venous events (deep venous thrombosis or pulmonary embolism), arterial events (acute coronary syndrome, stroke or peripheral arterial thrombosis) and death.
6. Measure, at D45 ± 1 week, the incidence of complications such as: venous/arterial thromboembolism, presence of hematoma requiring repeat surgery or associated with infection.
7. To explore the consistency and extent of the dose-response effect of tranexamic acid during the first postoperative week, the primary endpoint will also be measured at the end of surgery, at 24 hours, and on day 8.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Saint Etienne

Sponsor organisation

Centre Hospitalier Universitaire De Saint Etienne

Address

Avenue Albert Raimond

City

Saint-Priest-En-Jarez

Postcode

42270

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Saint Etienne

Contact name

Julien LANOISELEE

Public contact point

Organisation

Centre Hospitalier Universitaire De Saint Etienne

Contact name

Julien LANOISELEE

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications