Kraft 1987.
Methods | Study design: Randomized, double‐masked 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: Canada Dates: May 1978 to December 1984 Number randomized: 49: 24 to oral aminocaproic acid; 25 to placebo. Age: 3 to 18 years. Mean age: aminocaproic acid group 10.6 years, placebo group 11.2 years. Sex: 73% male. Race: 3 black participants in the aminocaproic acid group; 1 in the placebo group. The ethnicity or race of the other participants was not reported. Sickle cell disease: None; excluded. Participants appeared to be balanced with respect to baseline characteristics. Inclusion criteria: Children with non‐penetrating traumatic hyphema treated at the Hospital for Sick Children in Toronto, Canada. Exclusion criteria:
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Interventions | Treatment: Oral aminocaproic acid 100 mg/kg every 4 hours, for 5 days. Control: Placebo every 4 hours for 5 days. Treatment for both groups included:
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Outcomes | Primary outcome: Risk of secondary hemorrhage, assessed daily by slit‐lamp exam; documented by 2 observers and defined as definite increase in amount of blood compared with amount at admission or fresh red blood over darker clotted blood. Secondary outcomes: Outcomes measured daily during hospitalization (up to 5 days), then at 6 weeks, and 3, 6, 12, and 18 months after discharge.
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants assigned to treatment groups using computerized randomization. |
Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not reported. |
Blinding (performance bias and detection bias) Participants | Low risk | Authors used a placebo control and stated that the study was double‐masked. |
Blinding (performance bias and detection bias) Personnel and outcome assessors | Low risk | Authors used a placebo control and stated that the study was double‐masked. |
Incomplete outcome data (attrition bias) Primary outcome | Low risk | There was no loss to follow‐up, and all participants were analyzed in the group to which they had been randomly assigned. |
Incomplete outcome data (attrition bias) Secondary outcomes | Low risk | There was no loss to follow‐up, and 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. |