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. 2016 Mar 15;2016(3):CD009733. doi: 10.1002/14651858.CD009733.pub3

Gallardo 1983.

Methods Parallel RCT. Abstract. Single centre: USA. Enrolment period not stated
Participants Inclusion criteria: adults undergoing remission induction for acute leukaemia. No other inclusion criteria stated.
Exclusion criteria: not stated
N = 19 were eligible. N = 9 in each arm (AML N = 15; ALL N = 4). N = 1 was not evaluable (reason not stated). Distribution of subtypes in to each arm not stated.
Arm 1 N = 9
Arm 2 N = 9
Interventions Comparison between EACA therapy and no EACA therapy.
Arm 1 N = 9 (to receive EACA 100 mg/kg loading dose and 12 to 24 g/day in divided doses)
Arm 2 N = 9 (did not receive EACA)
RBC transfusion threshold: not stated
Platelet transfusion threshold: participants in both arms were administered platelet transfusion (dose and source not stated) when platelet count < 20 x 109/L. This threshold defined the "days at risk of bleeding".
Outcomes Main or primary outcomes not stated.
Outcomes reported:

  • Bleeding; either as capillary bleeding (CB; skin, mucous membranes, conjunctivae, nose, guaiac in GI or GU tract) or major bleeding (MB; nose bleeding requiring posterior packing, gross GI or GU bleeding and CNS bleeding

  • Monitoring of antifibrinolytic therapy using I125 fibrinogen plasma clot lysis

  • Platelet transfusion requirement

  • Adverse events of antifibrinolytic

  • Thromboembolism


Number of days participants on study: not reported
Notes Participants randomised at: not reported
Follow‐up of participants: not reported
Stopping guidelines: not reported
Funding: not reported
Declarations of interest: not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit a judgement of 'high' or 'low' risk.
Allocation concealment (selection bias) Unclear risk Insufficient information to permit a judgement of 'high' or 'low' risk
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to permit a judgement of 'high' or 'low' risk. The abstract does not state whether investigators and participants were blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit a judgement of 'high' or 'low' risk. The abstract does not state who carried out the bleeding assessments.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Insufficient information to permit a judgement of 'high' or 'low' risk
Selective reporting (reporting bias) High risk There are data for thromboembolism and death ("no patient died of thrombosis"), but no data given on number episodes of thromboembolism or number of deaths. No data reported monitoring of antifibrinolytic therapy using I125 fibrinogen plasma clot lysis
Other bias Unclear risk The “at risk of bleeding days” were much higher in the EACA group – 158 vs. 80 due to more severe thrombocytopenia and more cycles of chemotherapy for refractory disease. There may be bias in the randomisation procedure but method of randomisation is not stated.
Protocol deviation balanced? Unclear risk Protocol deviations or violations were not commented on