Traumatic HaemorrhagePhase 1/2TraumaINTACTNCT03875937
The Trauma INtramuscular Tranexamic Acid Clinical Trial
A Phase 1/2 study testing Tranexamic 1 gram in people with Traumatic Haemorrhage, run by London School of Hygiene and Tropical Medicine at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Traumatic Haemorrhage
- What is being tested?
- Tranexamic 1 gram
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 17 Sep 2019to 12 Feb 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The Royal London Hospital
London, E1 1FR
St George's Hospital
London, SW17 0QT
About this study
Official title: 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
Read the 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.
- Conditions
- Traumatic Haemorrhage
- Being tested
- Tranexamic 1 gram
- Keywords
- tranexamic acid, pharmacokinetic, intramuscular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic 1 gramDrug
To be administered intramuscularly (2 injections)
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid 1 gram intramuscularly | Experimental | 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. Receives: Drug: Tranexamic 1 gram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of serum TXA concentrations over time.
Measured: Blood samples will be taken pre-dose and up to 11 hours after IM TXA
Secondary outcomes (2)
Number of participants with Injection sites reactions
Measured: death, discharge or day seven (whichever comes first)
Number of adverse events reported by type
adverse events will be coded using MedDRA
Measured: death, discharge or day 7 (whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start17 Sep 2019
- Primary completion12 Feb 2020
- Study completion12 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic HaemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, open-label, multicentre, pharmacokinetic study.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Barts & The London NHS Trust, St George's University Hospitals NHS Foundation Trust, University of Versailles, JP Moulton Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Haleema Shakur-Still, Principal investigator, London School of Hygiene and Tropical MedicineIan Roberts, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875937
- Sponsor's protocol ID
- 2019/KEP/218
- Other IDs
- 2019-000898-23, 2019
- Acronym
- TraumaINTACT
- Status last verified
- Feb 2020
- First submitted
- 13 Mar 2019
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Dataset used for main analysis will be made freely available
Publications
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.
PubMed 33010927
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Intramuscular Tranexamic Acid in Trauma Patients: a Clinical Trial
- ClinicalTrials.gov ID
- NCT03875937
- Acronym / sponsor ID
- TraumaINTACT / 2019/KEP/218
- Conditions
- Traumatic Haemorrhage
- Keywords
- tranexamic acid, pharmacokinetic, intramuscular
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Barts & The London NHS Trust, St George's University Hospitals NHS Foundation Trust, University of Versailles, JP Moulton Charitable Foundation
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 12 Feb 2020 (actual)
- First posted
- 15 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, open-label, multicentre, pharmacokinetic study.
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid 1 gram intramuscularly | Experimental | Drug: Tranexamic 1 gramPatients 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic 1 gramTo be administered intramuscularly (2 injections) | Drug | Tranexamic acid 1 gram intramuscularly |
Primary outcome
Concentration of serum TXA concentrations over time.
Time frame: Blood samples will be taken pre-dose and up to 11 hours after IM TXA
2 secondary outcomes
Number of participants with Injection sites reactions
Time frame: death, discharge or day seven (whichever comes first)
Number of adverse events reported by type
Time frame: death, discharge or day 7 (whichever comes first)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Derived from this study: PubMed 33010927Grassin-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.
- Individual participant dataSharing planned: Yes. Dataset used for main analysis will be made freely available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haleema Shakur-Still principal investigator
London School of Hygiene and Tropical Medicine
Ian Roberts principal investigator
London School of Hygiene and Tropical Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tranexamic 1 gram in people with Traumatic Haemorrhage, run by London School of Hygiene and Tropical Medicine at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of serum TXA concentrations over time. (time frame: Blood samples will be taken pre-dose and up to 11 hours after IM TXA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03875937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.