Yutthakasemsunt 2013.
| Methods | Randomised controlled trial. | |
| Participants | 240 adults patients (>16 years) with moderate to severe traumatic brain injury (Glasgow Coma Scale 4 to 12) within 8 hours of injury. | |
| Interventions | Tranexamic acid group: 2 g (1 g loading dose over 30 minutes followed by maintenance dose of 1 g over 8 hours). Matching placebo. Setting: Thailand |
|
| Outcomes | Death in hospital. Progressive intracranial haemorrhage. Disability (GOS) (Teasdale 1974; Teasdale 1979). Thromboembolic events. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The randomisation sequence (with a randomly varied block size) was generated from a computer by a person who was not involved with the trial and this sequence was used to prepare the sequentially numbered treatment packs." (pg 3) |
| Allocation concealment (selection bias) | Low risk | "Whenever an eligible patient was recruited, the recruiting clinician asked that the next sequentially numbered sealed opaque treatment pack be opened and that the trial loading dose and maintenance infusion be prepared and sent to the relevant ward... Although drug and placebo vials contained an identical amount of colorless solution, there was a small size discrepancy between the drug and placebo vials. It was for this reason that the vials were enclosed within sequentially numbered sealed opaque envelopes that were opened by nurses who were not involved in the trial." (pg 3) |
| Blinding of participants and personnel (performance bias) Death, vascular occlusive events, intracranial bleeding | Low risk | "...those caring for the patient and those conducting the trial did not know the assigned treatment. The allocation scheme was kept confidential from all research participants until the end of the study." (pg 3) |
| Blinding of participants and personnel (performance bias) Surgical intervention, blood transfusion | Low risk | "...those caring for the patient and those conducting the trial did not know the assigned treatment. The allocation scheme was kept confidential from all research participants until the end of the study." (pg 3) |
| Blinding of outcome assessment (detection bias) Death, surgical intervention, blood transfusion | Low risk | "...those caring for the patient and those conducting the trial did not know the assigned treatment. The allocation scheme was kept confidential from all research participants until the end of the study." (pg 3) |
| Blinding of outcome assessment (detection bias) Vascular occlusive events, intracranial bleeding | Low risk | "...those caring for the patient and those conducting the trial did not know the assigned treatment. The allocation scheme was kept confidential from all research participants until the end of the study." (pg 3) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data were analysed on an intention‐to‐treat basis. A second CT scan could not be obtained for 9 patients (5 in TXA, 4 in placebo group). |
| Selective reporting (reporting bias) | Low risk | Trial was prospectively registered (NCT00755209) (pg 2). Data for all outcomes prespecified on registration record were presented in the final report. |
CT: computed tomography IV: intravenous TXA: tranexamic acid