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The Trauma INtramuscular Tranexamic Acid Clinical Trial (TraumaINTACT)

Primary Purpose

Traumatic Haemorrhage

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Tranexamic 1 gram
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Traumatic Haemorrhage focused on measuring tranexamic acid, pharmacokinetic, intramuscular

Eligibility Criteria

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

Inclusion Criteria:

  • Adult (appear to be at least 16 years old) trauma patients who have received 1 gram of intravenous TXA for the management of haemorrhage in whom a second dose is clinically indicated are eligible.

Exclusion Criteria:

  • none

Sites / Locations

  • The Royal London Hospital
  • St George's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tranexamic acid 1 gram intramuscularly

Arm Description

Patients will receive a 1 gram dose of TXA by IM injection at least 1 hour and 30 minutes after their initial IV injection received at the scene or on arrival to hospital. The IM dose will be given as two 5mL (0.5 gram each) injections into the thigh (rectus femoris or vastus lateralis), gluteal or deltoid muscles, depending on the clinical scenario (e.g. taking into account the type of injury). Injections should be given in a non-injured muscle.

Outcomes

Primary Outcome Measures

Concentration of serum TXA concentrations over time.

Secondary Outcome Measures

Number of participants with Injection sites reactions
Number of adverse events reported by type
adverse events will be coded using MedDRA

Full Information

First Posted
March 13, 2019
Last Updated
April 9, 2020
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Barts & The London NHS Trust, St George's University Hospitals NHS Foundation Trust, University of Versailles, JP Moulton Charitable Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03875937
Brief Title
The Trauma INtramuscular Tranexamic Acid Clinical Trial
Acronym
TraumaINTACT
Official Title
Pharmacokinetics of Intramuscular Tranexamic Acid in Trauma Patients: a Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 17, 2019 (Actual)
Primary Completion Date
February 12, 2020 (Actual)
Study Completion Date
February 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
Barts & The London NHS Trust, St George's University Hospitals NHS Foundation Trust, University of Versailles, JP Moulton Charitable Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Intramuscular injection of tranexamic acid (TXA) would increase its use in situations where administration of intravenous drugs is difficult. The investigators aim to assess the population pharmacokinetics of intramuscular TXA in trauma patients. Primary endpoint: Serum TXA concentrations over time. Secondary endpoints: Local reactions at injection sites and adverse events
Detailed Description
A prospective, open-label, multicentre, pharmacokinetic study conducted in the UK hospital. Potential eligible patients will have received a 1 gram IV dose of TXA at the scene of the injury or on arrival in hospital and a second dose is clinically indicated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Haemorrhage
Keywords
tranexamic acid, pharmacokinetic, intramuscular

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Prospective, open-label, multicentre, pharmacokinetic study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid 1 gram intramuscularly
Arm Type
Experimental
Arm Description
Patients will receive a 1 gram dose of TXA by IM injection at least 1 hour and 30 minutes after their initial IV injection received at the scene or on arrival to hospital. The IM dose will be given as two 5mL (0.5 gram each) injections into the thigh (rectus femoris or vastus lateralis), gluteal or deltoid muscles, depending on the clinical scenario (e.g. taking into account the type of injury). Injections should be given in a non-injured muscle.
Intervention Type
Drug
Intervention Name(s)
Tranexamic 1 gram
Intervention Description
To be administered intramuscularly (2 injections)
Primary Outcome Measure Information:
Title
Concentration of serum TXA concentrations over time.
Time Frame
Blood samples will be taken pre-dose and up to 11 hours after IM TXA
Secondary Outcome Measure Information:
Title
Number of participants with Injection sites reactions
Time Frame
death, discharge or day seven (whichever comes first)
Title
Number of adverse events reported by type
Description
adverse events will be coded using MedDRA
Time Frame
death, discharge or day 7 (whichever comes first)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (appear to be at least 16 years old) trauma patients who have received 1 gram of intravenous TXA for the management of haemorrhage in whom a second dose is clinically indicated are eligible. Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haleema Shakur-Still
Organizational Affiliation
LSHTM
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ian Roberts
Organizational Affiliation
LSHTM
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Royal London Hospital
City
London
ZIP/Postal Code
E1 1FR
Country
United Kingdom
Facility Name
St George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Dataset used for main analysis will be made freely available
IPD Sharing Time Frame
freely available 1 year after main publication
IPD Sharing Access Criteria
Free login to website required for monitoring usage of data
IPD Sharing URL
https://freebird.lshtm.ac.uk
Citations:
PubMed Identifier
33010927
Citation
Grassin-Delyle S, Shakur-Still H, Picetti R, Frimley L, Jarman H, Davenport R, McGuinness W, Moss P, Pott J, Tai N, Lamy E, Urien S, Prowse D, Thayne A, Gilliam C, Pynn H, Roberts I. Pharmacokinetics of intramuscular tranexamic acid in bleeding trauma patients: a clinical trial. Br J Anaesth. 2021 Jan;126(1):201-209. doi: 10.1016/j.bja.2020.07.058. Epub 2020 Sep 30.
Results Reference
derived

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The Trauma INtramuscular Tranexamic Acid Clinical Trial

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