ABSTRACT
BACKGROUND: Scoliosis surgeries in adults often have a high risk of massive blood loss and significant transfusion of blood products during and after surgery. It is not known whether early cryoprecipitate therapy is useful in reducing blood loss and transfusion requirements. The objective of this randomised, prospective placebo control study was to evaluate whether prophylactic administration of cryoprecipitate would reduce blood loss and transfusion requirements during scoliosis surgery. METHODS: Eighty adult patients scheduled to undergo elective scoliosis correction were randomly assigned to receive either ten units of cryoprecipitate before incision (cryo group) or an equivalent volume of 0.9% saline (placebo group). Blood loss, transfusion requirements, coagulation parameters and complications were assessed. RESULTS: No significant differences were found in the volume of transfused blood products, intraoperative estimated blood loss between the intervention and placebo groups. Postoperative blood loss was significantly lower in the cry group when compared to the other group. During adult surgical correction of scoliosis, prophylactic administration of cryoprecipitate did not diminish the amount of transfused blood products or decrease intraoperative blood loss. CONCLUSION: It could be concluded that the prophylactic administration of cryoprecipitate shows no differences in intraoperative blood loss and transfusion requirements during scoliosis surgery.
ABSTRACT
AIMS: Inhaled nebulised unfractionated heparin (UFH) has a strong scientific and biological rationale that warrants urgent investigation of its therapeutic potential in patients with COVID-19. UFH has antiviral effects and prevents the SARS-CoV-2 virus' entry into mammalian cells. In addition, UFH has significant anti-inflammatory and anticoagulant properties, which limit progression of lung injury and vascular pulmonary thrombosis. METHODS: The INHALEd nebulised unfractionated HEParin for the treatment of hospitalised patients with COVID-19 (INHALE-HEP) metatrial is a prospective individual patient data analysis of on-going randomised controlled trials and early phase studies. Individual studies are being conducted in multiple countries. Participating studies randomise adult patients admitted to the hospital with confirmed SARS-CoV-2 infection, who do not require immediate mechanical ventilation, to inhaled nebulised UFH or standard care. All studies collect a minimum core dataset. The primary outcome for the metatrial is intubation (or death, for patients who died before intubation) at day 28. The secondary outcomes are oxygenation, clinical worsening and mortality, assessed in time-to-event analyses. Individual studies may have additional outcomes. ANALYSIS: We use a Bayesian approach to monitoring, followed by analysing individual patient data, outcomes and adverse events. All analyses will follow the intention-to-treat principle, considering all participants in the treatment group to which they were assigned, except for cases lost to follow-up or withdrawn. TRIAL REGISTRATION, ETHICS AND DISSEMINATION: The metatrial is registered at ClinicalTrials.gov ID NCT04635241. Each contributing study is individually registered and has received approval of the relevant ethics committee or institutional review board. Results of this study will be shared with the World Health Organisation, published in scientific journals and presented at scientific meetings.
