Vangsted 1983.
Methods | Study design: Randomized clinical trial. Exclusions after randomization: None. Losses to follow‐up: None. Intention‐to‐treat: All participants were analyzed in the group to which they had been randomly assigned. Sample size calculations: Not reported. |
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Participants | Country: Sweden. Dates: November 1978 to May 1981. Number randomized: 112: 59 to tranexamic acid, 53 to bed rest. Age: Mean age: tranexamic acid group 23.5 years (range 9 to 60 years), bed rest group 23.5 years (range 9 to 67 years). Sex: Ratio of male:female 4:1. Race: Not reported. Sickle cell disease: Not reported. Participants appeared to be balanced with respect to baseline characteristics. Inclusion criteria: Traumatic hyphema. Exclusion criteria:
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Interventions | Treatment: Oral tranexamic acid 25 mg/kg 3 times/day, for 7 days. Control: Complete bed rest for 6 days. Treatment for both groups included:
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Outcomes | Primary outcome: Risk of secondary hemorrhage, assessed daily by slit‐lamp exam at days 2 and 7. Documentation and definition not reported. Secondary outcomes:
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomized, but method of allocation not reported. |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not reported. |
Blinding (performance bias and detection bias) Participants | High risk | Participants were not masked to treatment assignment (bed rest vs tranexamic acid). |
Blinding (performance bias and detection bias) Personnel and outcome assessors | High risk | Healthcare providers and outcome assessors were not masked to treatment assignment (bed rest vs tranexamic acid). |
Incomplete outcome data (attrition bias) Primary outcome | Low risk | There were no exclusions and no loss to follow‐up. All participants were analyzed in the group to which they had been randomly assigned. |
Incomplete outcome data (attrition bias) Secondary outcomes | Low risk | There were no exclusions and no loss to follow‐up. All participants were analyzed in the group to which they had been randomly assigned. |
Selective reporting (reporting bias) | Low risk | Reported results for primary and secondary outcomes |
Other bias | Low risk | No other sources of potential bias were identified. |