Results
bleeding, Administered, ®, allergic reaction, blood loss, thromboembolic, haemorrhage, rupture, mastitis, Fever, PPH
ENDOMETRITIS, BLEEDING, ALLERGIC REACTION, BLOOD LOSS, HAEMORRHAGE, SECONDARY, TRANSFUSION-ASSOCIATED CIRCULATORY OVERLOAD, MASTITIS, PYELONEPHRITIS, LYSIS, POSTPARTUM HAEMORRHAGE, COMPLICATIONS
The first participant was recruited on February 8, 2016, and the study ended on September 2, 2019; a total of 60 patients were randomised and 54 subjects were included in the final analysis. Subjects' baseline characteristics are presented in Baseline subject characteristics. For binominal variables, The primary endpoint data were available for 54 subjects. The median (25th–75th percentile) amount of transfused RBC units was 2 (1–4) in the ROTEM group and 3 (2–4) in control group (Administered OctaplasLG® units, medications, and surgical treatment modalities of PPH are listed in Use of procoagulant and uterotonic medications and other methods in treatment of postpartum haemorrhage. Laboratory values measuring the quality of haemostatic and haemodynamic management, such as haemoglobin, platelet count, TT-INR, aPTT, lactate, base excess, and ROTEM Extem and Fibtem values were determined at the beginning of treatment and 12–24 h afterwards. These parameters were also measured during treatment if considered necessary by the anaesthesiologist. Only Extem Maximal Lysis measured 12–24 h after treatment showed a significant difference (Key laboratory values at the beginning and 12–24 h after treatment. Clinically worse (lowest or highest) values during the study period and number of subjects exceeding protocol limits are also presented. Data expressed as mean (As a secondary endpoint, we assessed the number of complications possibly linked to treatment of haemorrhage. One transfusion-associated circulatory overload was noted in the ROTEM group. Fever was reported after transfusion in 4 (14.8%) subjects in each group. There were no reported thromboembolic complications. Two subjects (7.4%; endometritis, rupture of the incision) in the ROTEM group and 4 subjects (14.8%; pyelonephritis, bleeding, allergic reaction caused by antibiotics, mastitis) in the control group were admitted to hospital during the 30-day postpartum period (As a quality control, we monitored the blood product transfusion threshold during the study. This remained unchanged: among the first 15 consecutive patients recruited the median of total blood loss divided by number of RBC units administered was 1000 (762–1400), and the last 15 patients had a ratio of 825 (550–1050) (