SPINE
Efficacy and Safety of Antifibrinolytic Agents in Reducing Perioperative Blood Loss and Transfusion Requirements in Scoliosis Surgery: A Systematic Review and Meta-Analysis
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2015;3(24):32 PLoS One. 2015 Sep 18;10(9):e0137886.18 publications (9 RCTs) were included in this systematic review and meta-analysis comparing the use of antifibrinolytic agents against placebo for the treatment of patients diagnosed with scoliosis undergoing correction surgery. The purpose of this study was to determine if the antifibrinolytic agents aprotinin, tranexamic acid (TXA), and epsilon aminocaproic acid (EACA) were effective at safely reducing blood loss and transfusion requirements. Efficacy analyses were conducted using only randomized controlled trials and safety analyses were conducted using all included trials. The results of this study support the use of antifibrinolytic agents in the setting of scoliosis surgery as all three were found to successfully reduce total blood loss, blood loss during and after surgery, perioperative blood transfusion volume, and transfusion rate (RCTs) while having no effect on adverse events (all studies).
Were the search methods used to find evidence (original research) on the primary question or questions stated?
Was the search for evidence reasonably comprehensive?
Were the criteria used for deciding which studies to include in the overview reported?
Was the bias in the selection of studies avoided?
Were the criteria used for assessing the validity of the included studies reported?
Was the validity of all of the studies referred to in the text assessed with use of appropriate criteria (either in selecting the studies for inclusion or in analyzing the studies that were cited)?
Were the methods used to combine the findings of the relevant studies (to reach a conclusion) reported?
Were the findings of the relevant studies combined appropriately relative to the primary question that the overview addresses?
Were the conclusions made by the author or authors supported by the data and or analysis reported in the overview?
How would you rate the scientific quality of this evidence?
Ja = 1
Ungewiss = 0.5
Nicht relevant = 0
Nein = 0
Die Bewertung der Berichtskriterien bewertet die Transparenz, mit der die Autoren die methodischen und studienspezifischen Merkmale der Studie in der Veröffentlichung angeben. Die Bewertung ist in fünf Kategorien unterteilt, die im Folgenden vorgestellt werden.
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Introduction
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Accessing Data
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Analysing Data
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Results
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Discussion
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Der Fragilitätsindex ist ein Instrument, das bei der Interpretation signifikanter Ergebnisse hilft und ein Maß für die Stärke eines Ergebnisses liefert. Der Fragilitätsindex gibt die Anzahl der aufeinanderfolgenden Ereignisse an, die zu einem dichotomen Ergebnis hinzugefügt werden müssen, damit das Ergebnis nicht mehr signifikant ist. Eine kleine Zahl steht für ein schwächeres Ergebnis und eine große Zahl für ein stärkeres Ergebnis.
Warum wurde diese Studie jetzt benötigt?
Scoliosis is a common deformity characterized by a lateral curvature of the spine. Surgical intervention is commonly associated with drastic blood loss requiring blood transfusion, which in itself carries the risk of further complications. Antifibrinolytic agents such as aprotinin, tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) have been hypothesized to reduce blood loss and blood transfusion requirements by inhibiting serine protease and suppressing fibrinolysis, however, at the outset of the present study, the efficacy and safety of antifibrinolytic agents in the setting of scoliosis surgery had yet to be thoroughly investigated, thus warranting this systematic review and meta-analysis.
Was war die wichtigste Forschungsfrage?
Are antifibrinolytic agents including aprotinin, tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) effective at safely reducing blood loss and the need for blood transfusion in the setting of scoliosis surgery?
Was waren die wichtigsten Ergebnisse?
- Antifibrinolytic agents were found to be significantly more effective than placebo in reducing total blood loss (8 RCTs, 450 patients, p<0.0001, I2=81%), intraoperative blood loss (8 RCTs, 450 patients, p=0.0002, I2=72%) and postoperative blood loss (6 RCTs, 322 patients=0.02, I2=93%). Significant heterogeneity was observed each comparison.
- Antifibrinolytic agents were found to be significantly more effective than placebo in reducing perioperative blood transfusion volume (6 RCTs, 253 patients, WMD=-474.98 [95% CI -754.67 to 195.30]; p=0.0009, I2=83%).
- Antifibrinolytic agents were found to be significantly more effective than placebo in reducing perioperative blood transfusion rate (8 RCTs, 450 patients, OR=0.38 [95% CI 0.25 to 0.58]; p<0.00001, I2= 9%).
- The subgroup analysis found TXA, EACA and aprotinin to all be significantly more effective than placebo in reducing total blood loss (p-values: 0.0004, 0.004, 0.005, respectively) and perioperative blood transfusion requirements (p-values: 0.02, 0.04 and 0.0001, respectively), however only TXA and aprotinin were more effective than placebo in reducing intraoperative blood loss (p-values: 0.001 and <0.0001) and blood transfusion rate (p-values: 0.03 and <0.00001, respectively).
- Safety analysis using all included trials (RCTs, cohorts and case controls) indicated no significant difference in terms of incidence of adverse events between antifibrinolytic agents and placebo (18 studies, 1,158 patients, OR=0.84 [95% CI 0.25 to 2.88]; p=0.78), where only 8 adverse events were recorded among all the included studies.
- The incidence of adverse events was found to be similar with the use of both TXA and aprotinin when compared to placebo (p-values: 0.76 and 0.95, respectively), no adverse events were observed with the use EACA.
Was sollte ich mir besonders merken?
Efficacy analysis using only randomized controlled trials found that all antifibrinolytic agents were more effective than placebo in reducing total blood loss, blood loss throughout and after surgery, perioperative blood transfusion volume and transfusion rate while having no effect on adverse events. The overall effectiveness of each type of antifibrinolytic agent (TXA, EACA and aprotinin) was found to be similar, however it should be noted that only TXA was successful in reducing postoperative blood loss compared to placebo. Safety analysis using all levels of evidence found not difference in adverse events.
Wie wird sich dies auf die Behandlung meiner Patienten auswirken?
The findings of this study support the use of antifibrinolytic agents in the setting of scoliosis surgery for the reduction of blood loss and blood transfusion. Despite the fact that this study presents evidence of reduced perioperative blood loss and transfusion requirements with no increased risk of adverse events with the use of antifibrinolytic agents, further multicenter, large-sample, double-blind RCTs are required to confirm the efficacy and safety of the three antifibrinolytic agents in spine surgery.
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