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rFVIIa efficacy against bleeding was defined by its control (if visually in circuits), the diminished need for blood-product transfusion, and no early recurrence.
Following Research and Development approvals, the study enrolled consecutive patients with severe traumatic bleeding at the different hospitals, where severe traumatic bleeding was defined by a transfusion need for four units or more of red cells and activation of a massive haemorrhage protocol (MHP).
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A bleed was defined by a specific code for an upper gastrointestinal nonvariceal bleed in either primary or secondary care who had a supporting code in the linked dataset (defined as a likely symptom, cause, therapy, investigation, or outcome of upper gastrointestinal hemorrhage).
Bleeding was defined with ELSO criteria (ELSO anticoagulation guidelines).
Major bleeding was defined as intracranial, pulmonary, retroperitoneal, or gastrointestinal bleeding found clinically or with imaging techniques.
We classified cases into upper and lower gastrointestinal bleeding; upper bleeding was defined as bleeding originating from the esophagus, stomach, and duodenum; lower bleeding was defined as bleeding arising from the colon or rectum.
Less-severe bleeding was defined as minor bleeding [ 5].
Major bleeding was defined as any bleeding requiring blood transfusion.
Minor bleeding was defined as bleeding that did not fulfill the criteria for major bleeding.
Other major bleeding was defined as severe bleeding other than intracranial bleeding.
Secondary outcome measures were different complications; defined as; a) Bleeding was defined as either mucosal bleeding (epistaxis or gum bleed) or Gastrointestinal (GI) bleed; b).
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