Scoliosis surgery is often associated with substantial blood loss and potential detrimental effects in children. Antifibrinolytic agents are often used to reduce perioperative blood loss. Clinical trials have evaluated their effect in children undergoing surgical correction of scoliosis but no systematic review has been published. We performed a systematic review on the efficacy and safety of antifibrinolytic drugs in children undergoing scoliosis surgery.
To assess the efficacy and safety of aprotinin, tranexamic acid and aminocaproic acid in reducing blood loss and transfusion requirements in children undergoing scoliosis surgery.
We searched CENTRAL (The Cochrane Library 2007, Issue 3), OVID MEDLINE (1950 to September 3rd 2007), LILACS (1992 to June 20th 2007) and EMBASE (1980 to July 23rd 2007). We also searched conference proceedings from 2003 to 2007 and the clinicaltrials.gov registry. No language restriction was applied.
We included blinded or unblinded randomized controlled trials that evaluated the effect of antifibrinolytics on perioperative blood loss in children that were 18 years of age or younger and undergoing scoliosis surgery.
Data collection and analysis
Two authors independently performed the data extraction. Primary outcomes were mortality and number of patients transfused. Secondary outcomes were number of patients transfused with allogeneic blood, amount of total blood transfused, total blood loss and adverse events. To assess heterogeneity we used the I2 test and for the quantitative analysis we used a fixed-effect model.
Six studies fulfilled the inclusion criteria. The total number of participants was 254, of whom 127 were allocated to placebo and 127 to antifibrinolytic drugs. Aprotinin, tranexamic acid and aminocaproic acid were evaluated in two studies each. All studies had placebo as the control group intervention. There were no deaths or any serious adverse events in any study, in either the active or the control group. The risk of being transfused was similar in patients receiving antifibrinolytic drugs or placebo. Antifibrinolytics drugs decreased the amount of blood transfused by 327 ml (95% CI -469.04 to -185.78) and the amount of blood loss by 427 ml (95% CI -602.51 to -250.56). There was no indication of publication bias, however, we cannot rule it out due to the small number of studies included.
The effect of antifibrinolytic drugs on mortality could not be assessed. Antifibrinolytic drugs reduced blood loss and the amount of blood transfused in children undergoing scoliosis surgery; however, their effect on the number of children requiring blood transfusion remains unclear. Aprotinin, tranexamic acid and aminocaproic acid seem to be similarly effective.