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Pharmacokinetics of Tranexamic Acid After Oral, Intramuscular or Intravenous Administration: a Prospective, Randomised, Cross-over Trial in Healthy Volunteers.

NCT ID: NCT03777488

Last Updated: 2020-11-18

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

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2020-10-14

Brief Summary

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This is a Phase 1 study which aims to determine the pharmacokinetics and local and systemic tolerance of tranexamic acid in healthy volunteers using a population approach after oral, intramuscular or intravenous administration. It will also determine the feasibility of measuring tranexamic acid in spots of dry capillary blood.

Detailed Description

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Fifteen healthy volunteers will receive in random order 1 gram of intravenous and intramuscular injections and 2 grams of oral tranexamic acid solution. Blood samples will be taken at:

* T0+ 5min (only for IV route)
* T0+30min
* T0+1h
* T0+2h
* T0+3h
* T0+4h
* T0+5h
* T0+6h
* T0+8h (only for IM and PO routes)
* T0+24h

Conditions

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Healthy Volunteer Study

Keywords

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pharmacokinetics, tranexamic acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Tranexamic acid Group 1

Participants will receive tranexamic acid in the following order:

First Dose: Intravenous Second Dose: Intramuscular Third Dose: Oral

Group Type EXPERIMENTAL

Tranexamic Acid 1 gram intravenously

Intervention Type DRUG

Intravenous tranexamic acid crossover to oral and intramuscular arms

Tranexamic acid 2 grams oral solution

Intervention Type DRUG

Oral tranexamic acid crossover to intravenous and intramuscular arms

Tranexamic acid 1 gram intramuscular

Intervention Type DRUG

Intramuscular tranexamic acid crossover to oral and intravenous arms

Tranexamic acid Group 2

Participants will receive tranexamic acid in the following order:

First Dose: Intravenous Second Dose: Oral Third Dose: Intramuscular

Group Type EXPERIMENTAL

Tranexamic Acid 1 gram intravenously

Intervention Type DRUG

Intravenous tranexamic acid crossover to oral and intramuscular arms

Tranexamic acid 2 grams oral solution

Intervention Type DRUG

Oral tranexamic acid crossover to intravenous and intramuscular arms

Tranexamic acid 1 gram intramuscular

Intervention Type DRUG

Intramuscular tranexamic acid crossover to oral and intravenous arms

Tranexamic acid Group 3

Participants will receive tranexamic acid in the following order:

First Dose: Intramuscular Second Dose: Intravenous Third Dose: Oral

Group Type EXPERIMENTAL

Tranexamic Acid 1 gram intravenously

Intervention Type DRUG

Intravenous tranexamic acid crossover to oral and intramuscular arms

Tranexamic acid 2 grams oral solution

Intervention Type DRUG

Oral tranexamic acid crossover to intravenous and intramuscular arms

Tranexamic acid 1 gram intramuscular

Intervention Type DRUG

Intramuscular tranexamic acid crossover to oral and intravenous arms

Tranexamic acid Group 4

Participants will receive tranexamic acid in the following order:

First Dose: Intramuscular Second Dose: Oral Third Dose: Intravenous

Group Type EXPERIMENTAL

Tranexamic Acid 1 gram intravenously

Intervention Type DRUG

Intravenous tranexamic acid crossover to oral and intramuscular arms

Tranexamic acid 2 grams oral solution

Intervention Type DRUG

Oral tranexamic acid crossover to intravenous and intramuscular arms

Tranexamic acid 1 gram intramuscular

Intervention Type DRUG

Intramuscular tranexamic acid crossover to oral and intravenous arms

Tranexamic acid Group 5

Participants will receive tranexamic acid in the following order:

First Dose: Oral Second Dose: Intravenous Third Dose: Intramuscular

Group Type EXPERIMENTAL

Tranexamic Acid 1 gram intravenously

Intervention Type DRUG

Intravenous tranexamic acid crossover to oral and intramuscular arms

Tranexamic acid 2 grams oral solution

Intervention Type DRUG

Oral tranexamic acid crossover to intravenous and intramuscular arms

Tranexamic acid 1 gram intramuscular

Intervention Type DRUG

Intramuscular tranexamic acid crossover to oral and intravenous arms

Tranexamic acid Group 6

Participants will receive tranexamic acid in the following order:

First Dose: Oral Second Dose: Intramuscular Third Dose: Intravenous

Group Type EXPERIMENTAL

Tranexamic Acid 1 gram intravenously

Intervention Type DRUG

Intravenous tranexamic acid crossover to oral and intramuscular arms

Tranexamic acid 2 grams oral solution

Intervention Type DRUG

Oral tranexamic acid crossover to intravenous and intramuscular arms

Tranexamic acid 1 gram intramuscular

Intervention Type DRUG

Intramuscular tranexamic acid crossover to oral and intravenous arms

Interventions

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Tranexamic Acid 1 gram intravenously

Intravenous tranexamic acid crossover to oral and intramuscular arms

Intervention Type DRUG

Tranexamic acid 2 grams oral solution

Oral tranexamic acid crossover to intravenous and intramuscular arms

Intervention Type DRUG

Tranexamic acid 1 gram intramuscular

Intramuscular tranexamic acid crossover to oral and intravenous arms

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult healthy volunteers both men and non-pregnant women
* ≥18-≤45-year-old
* Body mass index between ≥18 and ≤30 kg/m2, and bodyweight between ≥50 and ≤100 kg
* Coagulation test results of fibrinogen, D-dimers, prothrombin time and a partial thromboplastin time within normal limits at screening
* Normal renal function based on medical history and laboratory tests
* If a woman, must have a negative urine β-human chorionic gonadotropin (βhCG) pregnancy test at screening and inclusion visits
* Provision of signed informed consent prior to any study specific procedure
* People with public healthcare insurance (in France)

Exclusion Criteria

* Previous thrombotic event or pre-existing pro-thrombotic disease
* Any history of seizures
* Any chronic or active cardiovascular or renal disease
* Planned general anaesthesia or surgery in the 3 months following inclusion
* Pregnant and/or breastfeeding
* Known allergy to the study drugs or any of the excipients of the formulations
* Use of any prescription or non-prescription medication (other than hormonal contraception) within 7 days before the first dose of the study drug is scheduled
* Inability to give informed consent
* Previous participation during the year in clinical studies compensated for an amount incompatible with participation in this study, verified by recording in the national register of subjects participating in human research trials
* Legal criteria:

* People deprived of liberty by judicial or administrative decision
* Adult protected by law (France)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haleema Shakur-Still

Role: STUDY_CHAIR

London School of Hygiene and Tropical Medicine

Ian Roberts

Role: STUDY_CHAIR

London School of Hygiene and Tropical Medicine

Locations

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UFR Sciences de la Santé Simone Veil Université Versailles Saint Quentin en Yvelines

Montigny-le-Bretonneux, , France

Site Status

Unité de Recherche Clinique Paris Descartes Necker Cochin, Hôpital Necker-Enfants Malades

Paris, , France

Site Status

Countries

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France

References

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Grassin-Delyle S, Semeraro M, Lamy E, Urien S, Runge I, Foissac F, Bouazza N, Treluyer JM, Arribas M, Roberts I, Shakur-Still H. Pharmacokinetics of tranexamic acid after intravenous, intramuscular, and oral routes: a prospective, randomised, crossover trial in healthy volunteers. Br J Anaesth. 2022 Mar;128(3):465-472. doi: 10.1016/j.bja.2021.10.054. Epub 2022 Jan 5.

Reference Type DERIVED
PMID: 34998508 (View on PubMed)

Other Identifiers

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2018/KEP/205

Identifier Type: -

Identifier Source: org_study_id