- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03875937
The Trauma INtramuscular Tranexamic Acid Clinical Trial (TraumaINTACT)
April 9, 2020 updated by: London School of Hygiene and Tropical Medicine
Pharmacokinetics of Intramuscular Tranexamic Acid in Trauma Patients: a Clinical Trial
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
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, SW17 0QT
- St George's Hospital
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London, United Kingdom, E1 1FR
- The Royal London Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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To be administered intramuscularly (2 injections)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Concentration of serum TXA concentrations over time.
Time Frame: Blood samples will be taken pre-dose and up to 11 hours after IM TXA
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Blood samples will be taken pre-dose and up to 11 hours after IM TXA
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with Injection sites reactions
Time Frame: death, discharge or day seven (whichever comes first)
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death, discharge or day seven (whichever comes first)
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Number of adverse events reported by type
Time Frame: death, discharge or day 7 (whichever comes first)
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adverse events will be coded using MedDRA
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death, discharge or day 7 (whichever comes first)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Haleema Shakur-Still, LSHTM
- Principal Investigator: Ian Roberts, LSHTM
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 17, 2019
Primary Completion (Actual)
February 12, 2020
Study Completion (Actual)
February 12, 2020
Study Registration Dates
First Submitted
March 13, 2019
First Submitted That Met QC Criteria
March 14, 2019
First Posted (Actual)
March 15, 2019
Study Record Updates
Last Update Posted (Actual)
April 10, 2020
Last Update Submitted That Met QC Criteria
April 9, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/KEP/218
- 2019-000898-23 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD 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 Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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