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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000898-23 | EudraCT Number |
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| Name | Class |
|---|---|
| Barts & The London NHS Trust | OTHER |
| St George's University Hospitals NHS Foundation Trust | OTHER |
| University of Versailles | OTHER |
| JP Moulton Charitable Foundation |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic 1 gram | Drug | To be administered intramuscularly (2 injections) |
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| Measure | Description | Time Frame |
|---|---|---|
| Concentration of serum TXA concentrations over time. | Blood samples will be taken pre-dose and up to 11 hours after IM TXA |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Injection sites reactions | death, discharge or day seven (whichever comes first) | |
| Number of adverse events reported by type | adverse events will be coded using MedDRA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haleema Shakur-Still | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Ian Roberts | London School of Hygiene and Tropical Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal London Hospital | London | E1 1FR | United Kingdom | |||
| St George's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33010927 | Derived | 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. |
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Dataset used for main analysis will be made freely available
freely available 1 year after main publication
Free login to website required for monitoring usage of data
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| OTHER |
Prospective, open-label, multicentre, pharmacokinetic study.
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| death, discharge or day 7 (whichever comes first) |
| London |
| SW17 0QT |
| United Kingdom |