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. 2019 Jan 14;2019(1):CD005431. doi: 10.1002/14651858.CD005431.pub4

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.
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:

  1. Penetrating ocular injury

  2. More than 24 hours since trauma

  3. Requirement for immediate surgical intervention

  4. Positive sickle cell test or abnormal hematologic parameter

  5. History of bleeding disorder

  6. Ingestion of aspirin‐containing medication within 7 days of admission

  7. Pregnancy
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:

  1. bed rest with bathroom privileges;

  2. head of bed elevated 15°;

  3. patch on affected eye;

  4. no topical eye medications except antibiotic ointment for corneal abrasions;

  5. oral paracetamol (10 to 20 mg/kg every 4 hours, up to 650 mg/dose);

  6. no aspirin‐containing medications;

  7. up to 0.5 mg/kg per day diazepam for sedation if needed;

  8. topical timolol maleate 0.5% if IOP > 25 mmHg;

  9. dimenhydrinate (Gravol) 6.25 to 12.5 mg every 6 hours if vomiting or nausea.
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.

  1. Time to resolution of primary hemorrhage

  2. VA

  3. IOP assessed using applanation tonometry

  4. Risk of complications and adverse events
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.