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A Dose-response Study of Tranexamic Acid in Total Hip Arthroplasty (PRADO)

Primary Purpose

Arthropathy of Hip

Status

Not yet recruiting

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Placebo

Group 1: perfusion of 300 mg Exacyl

Group 2: perfusion of 500 mg Exacyl

Group 3: perfusion of 1000 mg Exacyl

Group 4: perfusion of 3000 mg Exacyl

About this trial

This is an interventional treatment trial for Arthropathy of Hip focused on measuring tranexamic acid (TXA), arthroplasty, hip, Exacyl

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

CHU Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Group 1: perfusion of 300 mg Exacyl

Group 2: perfusion of 500 mg Exacyl

Group 3: perfusion of 1000 mg Exacyl

Group 4: perfusion of 3000 mg Exacyl

Arm Description

Patient will be included in this group by randomization and they will receive a perfusion of NaCl (sodium chloride 9%; placebo) intravenous over 10 minutes just before surgery.

Patient will be included in the group 2 by randomization and they will receive a perfusion of 300 mg Exacyl (tranexamic acid) intravenous (IV) over 10 minutes just before surgery.

Patient will be included in the group 2 by randomization and they will receive a perfusion of 500 mg Exacyl (tranexamic acid) intravenous (IV) over 10 minutes just before surgery.

Patient will be included in the group 3 by randomization and they will receive a perfusion of 1000 mg Exacyl (tranexamic acid) intravenous (IV) over 10 minutes just before surgery.

Patient will be included in the group 4 by randomization and they will receive a perfusion of 3000 mg Exacyl (tranexamic acid) intravenous (IV) over 10 minutes just before surgery.

Outcomes

Primary Outcome Measures

haemoglobin decrease in the perioperative period

Percentage of haemoglobin change in the perioperative period. It requires the sampling of haemoglobin before surgery and on the eighth postoperative day.

Secondary Outcome Measures

Evolution of the concentration of tranexamic acid

For tranexamic acid pharmacokinetics, the outcome measure is the sampling of tranexamic blood concentration.

Evolution of the concentration of D-Dimer

For tranexamic acid pharmacodynamics, the outcome is the sampling of D-Dimer levels.

allogenic red blood cell transfusion

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.

severe anaemia

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.

incidence of symptomatic thrombotic events and death

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.

occurrence of a seizure

Upon the occurrence of a seizure, the endpoint is a clinical endpoint involving either the observation of a generalized tonic-clonic seizure or a partial seizure or absence with epilepsy confirmed by an electroencephalogram interpreted by a blind neurologist in the patient's inclusion group.

Full Information

NCT ID

NCT03822793

First Posted

December 31, 2018

Last Updated

June 19, 2023

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

1. Study Identification

Unique Protocol Identification Number

NCT03822793

Brief Title

A Dose-response Study of Tranexamic Acid in Total Hip Arthroplasty

Acronym

PRADO

Official Title

Dose Study of Tranexamic Acid in Total Hip Replacement to Reduce Post-operative Hemoglobin Loss: A Phase 2 Randomized Double-blind Monocentric Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 2023 (Anticipated)

Primary Completion Date

December 2026 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A single preoperative dose of tranexamic acid (TXA) reduces blood loss and red blood cell transfusion in primary hip arthroplasty. Numerous regimens have been tested, ranging from 10mg/kg up to 3g. However the optimal dose to administer is unknown.

Detailed Description

This dose-response study is a randomized double blind study with five groups of 30 patients each. Patients will be randomized to placebo, tranexamic acid (TXA) 300 mg, tranexamic acid (TXA) 500 mg, tranexamic acid (TXA) 1000 mg or tranexamic acid (TXA) 3000 mg. In addition a pharmacokinetic/pharmacodynamic study will be performed to identify the contribution of tranexamic acid (TXA) plasma concentration as a predictor of intra and postoperative D-Dimer values.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthropathy of Hip

Keywords

tranexamic acid (TXA), arthroplasty, hip, Exacyl

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

randomized double blind study

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Patient will be included in this group by randomization and they will receive a perfusion of NaCl (sodium chloride 9%; placebo) intravenous over 10 minutes just before surgery.

Arm Title

Group 1: perfusion of 300 mg Exacyl

Arm Type

Experimental

Arm Description

Patient will be included in the group 2 by randomization and they will receive a perfusion of 300 mg Exacyl (tranexamic acid) intravenous (IV) over 10 minutes just before surgery.

Arm Title

Group 2: perfusion of 500 mg Exacyl

Arm Type

Experimental

Arm Description

Patient will be included in the group 2 by randomization and they will receive a perfusion of 500 mg Exacyl (tranexamic acid) intravenous (IV) over 10 minutes just before surgery.

Arm Title

Group 3: perfusion of 1000 mg Exacyl

Arm Type

Experimental

Arm Description

Patient will be included in the group 3 by randomization and they will receive a perfusion of 1000 mg Exacyl (tranexamic acid) intravenous (IV) over 10 minutes just before surgery.

Arm Title

Group 4: perfusion of 3000 mg Exacyl

Arm Type

Experimental

Arm Description

Patient will be included in the group 4 by randomization and they will receive a perfusion of 3000 mg Exacyl (tranexamic acid) intravenous (IV) over 10 minutes just before surgery.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Patient will receive a perfusion of NaCl (sodium chloride 9%; placebo) intravenous over 10 minutes just before surgery.

Intervention Type

Drug

Intervention Name(s)

Group 1: perfusion of 300 mg Exacyl

Intervention Description

Patient will receive a perfusion of 300 mg Exacyl (tranexamic acid) intravenous (IV) over 10 minutes just before surgery.

Intervention Type

Drug

Intervention Name(s)

Group 2: perfusion of 500 mg Exacyl

Intervention Description

Patient will receive a perfusion of 500 mg Exacyl (tranexamic acid) intravenous (IV) over 10 minutes just before surgery.

Intervention Type

Drug

Intervention Name(s)

Group 3: perfusion of 1000 mg Exacyl

Intervention Description

Patient will receive a perfusion of 1000 mg Exacyl (tranexamic acid) intravenous (IV) over 10 minutes just before surgery.

Intervention Type

Drug

Intervention Name(s)

Group 4: perfusion of 3000 mg Exacyl

Intervention Description

Patient will receive a perfusion of 3000 mg Exacyl (tranexamic acid) intravenous (IV) over 10 minutes just before surgery.

Primary Outcome Measure Information:

Title

haemoglobin decrease in the perioperative period

Description

Percentage of haemoglobin change in the perioperative period. It requires the sampling of haemoglobin before surgery and on the eighth postoperative day.

Time Frame

Day 8

Secondary Outcome Measure Information:

Title

Evolution of the concentration of tranexamic acid

Description

For tranexamic acid pharmacokinetics, the outcome measure is the sampling of tranexamic blood concentration.

Time Frame

Day 8

Title

Evolution of the concentration of D-Dimer

Description

For tranexamic acid pharmacodynamics, the outcome is the sampling of D-Dimer levels.

Time Frame

Day 8

Title

allogenic red blood cell transfusion

Description

Time Frame

Day 8

Title

severe anaemia

Description

Time Frame

Day 8

Title

incidence of symptomatic thrombotic events and death

Description

Time Frame

Day 8

Title

occurrence of a seizure

Description

Time Frame

Day 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient requiring primary hip arthroplasty (less than 3 months) Consent of the patient or a family member or the support person Exclusion Criteria: Contraindication to tranexamic acid Contraindication to apixaban Pregnancy Patient receiving a curative anticoagulating treatment in the preoperative period Bilateral or previous hip arthroplasty Hemorrhagic surgery less than 2 weeks old

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Julien LANOISELEE, MD

Phone

(0)477828554

Ext

+33

julien.lanoiselee@chu-st-etienne.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Béatrice DEYGAS, CRA

Phone

(0)477127655

Ext

+33

beatrice.deygas@chu-st-etienne.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julien LANOISELEE, MD

Organizational Affiliation

CHU Saint-Etienne

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Saint-Etienne

City

Saint-Étienne

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Julien LANOISELEE, MD

First Name & Middle Initial & Last Name & Degree

Paul ZUFFEREY, MD

First Name & Middle Initial & Last Name & Degree

Julie GALLAND-CARNESECCHI, MD

First Name & Middle Initial & Last Name & Degree

Jean-Yves BIEN, MD

First Name & Middle Initial & Last Name & Degree

Cédric DELZANNO, MD

First Name & Middle Initial & Last Name & Degree

Pierre LAMBERT, MD

First Name & Middle Initial & Last Name & Degree

Malik BAROUDI, MD

First Name & Middle Initial & Last Name & Degree

Zeina PRADES, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Dose-response Study of Tranexamic Acid in Total Hip Arthroplasty

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