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The Trauma INtramuscular Tranexamic Acid Clinical Trial (TraumaINTACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03875937
Recruitment Status : Completed
First Posted : March 15, 2019
Last Update Posted : April 10, 2020
Sponsor:
Collaborators:
Barts & The London NHS Trust
St George's University Hospitals NHS Foundation Trust
University of Versailles
JP Moulton Charitable Foundation
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

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


Condition or disease Intervention/treatment Phase
Traumatic Haemorrhage Drug: Tranexamic 1 gram Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, open-label, multicentre, pharmacokinetic study.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacokinetics of Intramuscular Tranexamic Acid in Trauma Patients: a Clinical Trial
Actual Study Start Date : September 17, 2019
Actual Primary Completion Date : February 12, 2020
Actual Study Completion Date : February 12, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tranexamic acid 1 gram intramuscularly
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.
Drug: Tranexamic 1 gram
To be administered intramuscularly (2 injections)




Primary Outcome Measures :
  1. 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 Measures :
  1. Number of participants with Injection sites reactions [ Time Frame: death, discharge or day seven (whichever comes first) ]
  2. Number of adverse events reported by type [ Time Frame: death, discharge or day 7 (whichever comes first) ]
    adverse events will be coded using MedDRA



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875937


Locations
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United Kingdom
The Royal London Hospital
London, United Kingdom, E1 1FR
St George's Hospital
London, United Kingdom, SW17 0QT
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Barts & The London NHS Trust
St George's University Hospitals NHS Foundation Trust
University of Versailles
JP Moulton Charitable Foundation
Investigators
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Principal Investigator: Haleema Shakur-Still LSHTM
Principal Investigator: Ian Roberts LSHTM
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03875937    
Other Study ID Numbers: 2019/KEP/218
2019-000898-23 ( EudraCT Number )
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Dataset used for main analysis will be made freely available
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: freely available 1 year after main publication
Access Criteria: Free login to website required for monitoring usage of data
URL: https://freebird.lshtm.ac.uk

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by London School of Hygiene and Tropical Medicine:
tranexamic acid
pharmacokinetic
intramuscular
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes