The aim of this clinical research project is to evaluate the use of the recombinant human activated factor VII (rhFVIIa), given as a salvage therapy, in women with a dramatic postpartum hemorrhage still ongoing after all the currently available medical and surgical treatments. We are going to compare its early use, before elective surgery or arterial embolization, to its late use, after embolization or surgery, before salvage hysterectomy.
Age range
18 Years – 45 Years
Sex
FEMALE
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Clinical parameters: intensity of the hemorrhage, before and one hour after the end of the rhuFVIIa infusion (use of a graduated blood collector bag device).
Timeframe: 1 hour
Any transfusion (number of units and volume) of red blood cells, platelet or fresh frozen plasma. Haemodynamics-related parameters (non-invasive arterial pressure,heart rate, diuresis,..).
Timeframe: 7 Hours
Biological parameters:packed red cell volume, hemoglobin, etc.
Timeframe: 12 hours
Therapeutic interventions aiming at controlling postpartum hemorrhage: selective arterial embolization, ligation of hypogastric arteries, hysterectomy.
Timeframe: Day 1