“UniSeven” - Registry for Life Threatening Bleeding Treated with rFVIIa. Medical and Technical Background and First Output.
Authors: Blatny Jan , Dusek Ladislav , Smid Roman , Penka Miroslav 
Published: October 2019

Massive haemorrhage is a major cause of death in trauma patients. In military trauma cases the exsanquination is the reason of death in 44% (WDMET Vietnam war 1967–1969, 8000 casualties) In civilian trauma 39% of patients die because of massive haemorrhage. (Sauaia A et al. J. Trauma, 1995; 38:185–193). Massive bleeding is responsible for the death of more than 80% of trauma patients in the operating room (Hoyt DB et al. J. Trauma; 37: 426–432). There are also other medical specialisations which are faced with the problem of massive haemorrhage.

Pathogenesis of life threatening bleeding is a complex problem not only in trauma patient. It is influenced by dilution coagulopathy, acidosis and other metabolic changes, thrombocytopenia and functional disorders of platelets, hypothermia and others. In fact all these problems lead - by different ways - to the thrombin formation disorders. Ineffective or inappropriate formation of thrombin than leads to defective or even no clot formation. If we were able to re-establish the proper thrombin formation, we would be theoretically able to solve most problems caused by massive haemorrhage in our patients.

This is the theoretical basis for the use of rFVIIa as a potentially universal haemostatic agent in life-threatening bleeding. As the activity of rFVIIa is limited on the surfaces containing TF and phosphatidylserine - compartment physiologically active in normal clot formation - treatment with rFVIIa is probably one of the most save and most physiological way of treatment for such a bleeding. To support the evidence for the treatment of life-threatening bleeding with rFVIIa we have designed the software which registers individual cases when rFVIIa has been administered to control massive haemorrhage. This powerful tool will be able to provide its users with multiple outcomes and presentations based on statistically significant data. We believe that UniSeven registry will be useful for both intensive care givers and patients and that it will help to save numbers of human lives.

Our work presents the technological background of the registry as well as first output from the registry based on data from more than 100 patients treated with rFVIIa mainly for life-threatening bleeding as a complication of trauma, surgery, cardiac surgery and malignancy in Czech Republic in years 2001– 2003. Up to now rFVIIa was administered in 114 cases in patients aged 0–80 years whose bleeding was refractory to standard therapeutical measures and threatens the patients′ lives.In 28, 57% the reason for rFVIIa administration was bleeding in trauma, 10, 7% cardiac surgery, 1, 79% gynaecology/obstetrics, 0, 89% intracranial haemorrhage and in 58% other reasons for uncontrolled bleeding. In 17 cases (15, 04%) rFVIIa was administered as a prophylaxis and in 96 cases (84, 9%) for treatment of life-threatening bleeding. Median dose of rFVIIa when administered for treatment of uncontrolled bleeding was 100 ug/kg and 1–2 doses was sufficient to treat the bleeding in more than 80% of cases. Such a treatment led to decrease of Packed cells transfusions from 7, 5 TU (median 24 h prior to rFVIIa administration) to 2 TU (median 24 h post rFVIIa administration). In our hands 62, 5% of patients with life threatening bleeding treated with rFVIIa survived. No death was related to rFVIIa treatment and we did not notice any serious adverse event related to rFVIIa treatment