Rahmani 1999.
Methods | Study design: Randomized, placebo‐controlled clinical trial. Exclusions after randomization: 6: 2 participants in the tranexamic acid group, 3 in the prednisone group, and 1 in the placebo group left the hospital before the end of the study and were excluded. Losses to follow‐up: None. Intention‐to‐treat: The excluded participants were not included in the analyses, and the intention‐to‐treat principle was not followed in the analyses. Sample size calculations: Not reported. |
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Participants | Country: Iran. Dates: January 1991 to May 1992. Number randomized: 244: 82 to tranexamic acid, 81 to prednisone, 81 to placebo. Age: Median age: tranexamic acid 11 years (range 1 to 65 years); prednisone 11.5 years (range 1 to 50 years); placebo 12 years (range 1 to 58 years). Sex: 63 participants (79%) in tranexamic acid group, 58 participants (73%) in prednisone group, and 66 participants (82%) in placebo group were male. Race: 100% white. Sickle cell disease: Not reported, but all‐white study population. Participants appeared to be balanced with respect to baseline characteristics. Inclusion criteria: Traumatic hyphema. Exclusion criteria:
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Interventions | Treatment 1: Oral tranexamic acid 75 mg/kg per day, divided into 3 doses/day, for 5 days. Treatment 2: Oral prednisolone 0.75 mg/kg per day, divided into 2 doses/day, for 5 days. Control: Placebo administered 3 times/day. Treatment for all groups included:
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Outcomes | Primary outcome: Risk of secondary hemorrhage, assessed daily by slit‐lamp exam for 5 days. Defined as definite increase in size of level of blood or appearance of fresh blood over darker clotted blood in the anterior chamber. Secondary outcomes:
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization was based on a randomization list. |
Allocation concealment (selection bias) | Unclear risk | Participants were assigned to treatment groups using a randomization list, but it was not clear whether list was revealed before allocation to individuals enrolling participants. |
Blinding (performance bias and detection bias) Participants | Unclear risk | Participants partially masked as authors used a placebo control for the tranexamic acid, but not for prednisone. |
Blinding (performance bias and detection bias) Personnel and outcome assessors | Low risk | Healthcare providers partially masked as authors used a placebo control for the tranexamic acid, but not for prednisone; however, ophthalmologists and outcome assessors were masked. |
Incomplete outcome data (attrition bias) Primary outcome | Unclear risk | 6 participants were excluded from the study: 2 in the tranexamic acid group, 3 in the prednisone group, and 1 in the placebo group left the hospital before the end of the study and were excluded. The excluded participants were not included in the analyses, and the intention‐to‐treat principle was not followed in the analyses. |
Incomplete outcome data (attrition bias) Secondary outcomes | Unclear risk | 6 participants were excluded from the study: 2 in the tranexamic acid group, 3 in the prednisone group, and 1 in the placebo group left the hospital before the end of the study and were excluded. The excluded participants were not included in the analyses, and the intention‐to‐treat principle was not followed in the analyses. |
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. |