The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Single intravenous infusion
Single intravenous infusion
Medical School Hannover (MHH)
Hanover, Germany
Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects.
Time frame: From administration of Haemocomplettan® P until 24 hours later
Proportion of subjects that receive no allogeneic blood products (neither platelets, FFP, nor RBCs)
Time frame: From administration of Haemocomplettan® P until 24 hours later
Duration of stay in ICU
Time frame: Last suture of initial surgery to end of ICU stay
Duration of hospital stay
Time frame: Last suture of initial surgery to end of hospital stay
Mortality
Time frame: 45 days post surgery
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