Survey on Clinically Relevant Bleeding

Confidential Page 1 of 18 Survey on Clinically Relevant Bleeding Thank you for having accepted to participate in this research project. We all know when a patient is presenting with a clinically relevant bleeding episode, but it is difficult to have an operational definition that can be used for research. The goal of this survey is to understand what pediatric critical care providers consider a clinically relevant bleed. Some might define "clinically relevant" as an increased risk of worse outcome, others as the requirement for more support, or as increased costs, etc. For each of the following items, please indicate how you would qualify the clinical significance of the bleeding in the following scenarios. We do realize that it will sometimes be difficult for you to answers as the significance of bleeding might depend on the clinical context. Unfortunately, a survey does not allow to capture the complexity of real-life situations. If you do not feel comfortable with the wording of the questions, please feel free to move to the next question or to end the survey. Thank you for having accepted to participate in this research project. We all know when a patient is presenting with a clinically relevant bleeding episode, but it is difficult to have an operational definition that can be used for research. The goal of this survey is to understand what pediatric critical care providers consider a clinically relevant bleed. Some might define "clinically relevant" as an increased risk of worse outcome, others as the requirement for more support, or as increased costs, etc. For each of the following items, please indicate how would you qualify the clinical significance of the bleeding in the following scenarios. We do realize that it will sometimes be difficult for you to answers as the significance of bleeding might depend on the clinical context. Unfortunately, a survey does not allow to capture the complexity of real-life situations. If you do not feel comfortable with the wording of the questions, please feel free to move to the next question or to end the survey. For each item, how would you qualify the clinical significance of the bleeding in the following scenarios? Not Somewh Definitiv clinically at ely relevant clinically clinically relevant relevant Intracranial extraparenchymal bleeding with signs of increased ICP or midline shift Intracranial intra-parenchymal bleeding without signs of increased ICP Intraorbital or intra-ocular bleeding with visual change Bleeding in the spinal cord Bleeding from arterio-venous malformations Bleeding ruptured aneurysms 08/11/2018 11:20pm projectredcap.org Confidential Page 2 of 18 For each item, how would you qualify the clinical significance of the bleeding in the following scenarios? Not Somewh Definitiv clinically at ely relevant clinically clinically relevant relevant Bleeding leading to a drop in hemoglobin by > 20% Bleeding leading to a drop in hemoglobin by 10 to 20% Bleeding leading to a drop in hemoglobin by < 10% Bleeding leading to a drop in hemoglobin by > 2 g/dL (20 g/L) Bleeding leading to a drop in hemoglobin by 1 to 2 g/dL (10 to 20 g/L) Bleeding leading to a drop in hemoglobin by < 1 g/dL (10 g/L) 08/11/2018 11:20pm projectredcap.org Confidential Page 3 of 18 For each item, how would you qualify the clinical significance of the bleeding in the following scenarios? Not Somewh Definitiv clinically at ely relevant clinically clinically relevant relevant Bleeding leading to hypovolemia with signs of hypoperfusion Bleeding leading to hypovolemia without signs of hypoperfusion Bleeding leading to increase in lactate above 3 mmol/L (27 mg/dL) Bleeding with normal lactate (< 3 mmol/L (27 mg/dL)) Bleeding leading to drop in SvO2 below 65% Bleeding with normal SvO2 (above 70%) 08/11/2018 11:20pm projectredcap.org Confidential Page 4 of 18 For each item, how would you qualify the clinical significance of the bleeding in the following scenarios? Not Somewh Definitiv clinically at ely relevant clinically clinically relevant relevant Bleeding associated with a drop in systolic blood pressure by > 20% Bleeding associated with a drop in systolic blood pressure by 10 to 20% Bleeding associated with a drop in systolic blood pressure by < 10% Bleeding associated with an increase in heart rate by > 20% Bleeding associated with an increase in heart rate by 10 to 20% Bleeding associated with an increase in heart rate by < 10% 08/11/2018 11:20pm projectredcap.org Confidential Page 5 of 18 For each item, how would you qualify the clinical significance of the bleeding in the following scenarios? Not Somewh Definitiv clinically at ely relevant clinically clinically relevant relevant Bleeding leading to a drop in platelets by > 33% from baseline Bleeding leading to a drop in platelets by < 33% from baseline Bleeding leading to a increase in INR by > 0.5 from baseline Bleeding leading to a increase in INR by < 0.5 from baseline Bleeding leading to a drop in fibrinogen by > 35% from baseline Bleeding leading to a drop in fibrinogen by < 35% from baseline Bleeding leading to a increased time to thrombin generation Bleeding leading to hyperfibrinolysis 08/11/2018 11:20pm projectredcap.org Confidential Page 6 of 18 For each item, how would you qualify the clinical significance of the bleeding in the following scenarios? Not Somewh Definitiv clinically at ely relevant clinically clinically relevant relevant Bleeding leading to fluid replacement Bleeding leading to red blood cell transfusion Bleeding leading to plasma transfusion Bleeding leading to platelet transfusion Bleeding leading to cryo or fibrinogen infusion Bleeding leading to rFVIIa infusion Bleeding in which red blood cell transfusion fails to increase hemoglobin level 08/11/2018 11:20pm projectredcap.org Confidential Page 7 of 18 When considering quantifiable bleeding, such as from < 1 ml/kg/hr a chest tube, what would be the volume that you > 1 ml/kg/hr would consider "definitively clinically relevant" > 2 ml/kg/hr (the duration of bleeding is the next question)? > 3 ml/kg/hr > 5 ml/kg/hr > 7 ml/kg/hr > 10 ml/kg/hr How long must the patient be bleeding above the < 30 minutes previous threshold for you to consider it > 30 minutes "definitively clinically relevant"? > 1 hour > 2 hour > 4 hour > 6 hours 08/11/2018 11:20pm projectredcap.org Confidential Page 8 of 18 For each item, how would you qualify the clinical significance of the bleeding in the following scenarios? Not Somewh Definitiv clinically at ely relevant clinically clinically relevant relevant Tamponade with symptoms (chest pain) Tamponade with hemodynamic compromise Asymptomatic hemopericardium Pulmonary intraparenchymal bleeding with respiratory distress Pulmonary intraparenchymal bleeding with increase in FiO2 Pulmonary intraparenchymal bleeding even without respiratory distress Hemothorax with clinical repercussions (respiratory distress or cardiovascular compromise) Hemothorax without clinical repercussions (asymptomatic) 08/11/2018 11:20pm projectredcap.org Confidential Page 9 of 18 For each item, how would you qualify the clinical significance of the bleeding in the following scenarios? Not Somewh Definitiv clinically at ely relevant clinically clinically relevant relevant Bleeding not resolving within 6 hours Bleeding resolving within 2 to 6 hours Bleeding resolving in less than 2 hours 08/11/2018 11:20pm projectredcap.org Confidential Page 10 of 18 For each item, how would you qualify the clinical significance of the bleeding in the following scenarios? Not Somewh Definitiv clinically at ely relevant clinically clinically relevant relevant Bleeding leading to hospital admission Bleeding leading to pediatric critical care admission Bleeding leading to prolonged surgical time for hemostasis Bleeding requiring operative intervention Bleeding requiring procedure (e.g. chest tube insertion) Bleeding requiring requesting coagulation tests 08/11/2018 11:20pm projectredcap.org Confidential Page 11 of 18 For each item, how would you qualify the clinical significance of the bleeding in the following scenarios? Not Somewh Definitiv clinically at ely relevant clinically clinically relevant relevant Post-op oro-pharyngeal bleeding with respiratory distress Retroperitoneal bleeding Abdominal compartment syndrome due to bleeding Moderate abdominal bleeding following trauma (as evaluated by ultrasound) Minimal abdominal bleeding following trauma (as evaluated by ultrasound) Bleeding in limbs with compartment syndrome Intra-articular, with pain and/or decreased range of motion Intra-articular, asymptomatic 08/11/2018 11:20pm projectredcap.org Confidential Page 12 of 18 How would the following items influence the likelihood of clinically relevant bleeding? Decreas No Increase e the change s the likelihoo in the likelihoo d of likelihoo d of clinically d of clinically relevant clinically relevant bleeding relevant bleeding bleeding Patient on anticoagulant Patient on anti-platelet therapy Patient with primary coagulopathy (e.g. hemophilia) Patient with secondary coagulopathy (e.g. liver failure) Patient with reduced platelet function Patient with reduced fibrinogen function Bleeding in the context of ongoing hemodynamic instability Bleeding in the context of signs of impaired oxygen delivery 08/11/2018 11:20pm projectredcap.org Confidential Page 13 of 18 For each item, how would you qualify the clinical significance of the bleeding in the following scenarios? Not Somewh Definitiv clinically at ely relevant clinically clinically relevant relevant Rectal bleeding, more than streaks of blood

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