The goal of this trial is to determine if postpartum blood loss can be reduced by replenishing coagulation factor XIII (FXIII) at an early stage of postpartum hemorrhage (PPH).
Summary of current body of evidence:
* Morbidity and mortality due to PPH is rising. * Current guidelines focus on replenishment of fibrinogen as an initial step in the treatment of PPH-related coagulopathy, despite non-conclusive evidence in all prospective trials. * Trials from other specialties demonstrate a significant impact of FXIII on perioperative bleeding complications; a previous study at the University Hospital Zurich showed that pre-partum factor XIII activity had a strong association to postpartum blood loss.
Therefore, this nationwide, multi-center, randomized, controlled trial in multiple perinatal centers across Switzerland will be conducted. The goal is to determine if postpartum blood loss and PPH-related complications can be reduced by replenishing FXIII.
All participating women receive, according to the national guideline, 1g tranexamic acid (TXA) i.v. in case of PPH (measured blood loss \[MBL\] ≥ 500 mL) during the pre-study phase. Randomization takes place if bleeding continues and exceeds 700mL. The intervention group then receives FXIII (Fibrogammin®) according to approved dosage in addition to obstetric standard of care treatment for causes of PPH; the control group receives only standard of care treatment.
planned vaginal delivery
singleton vital pregnancy
gestational age at delivery >= 30+0 weeks
maternal weight at admission for delivery <100 kg
Antithrombotic therapy in pregnancy (therapeutic dosage) until admission for delivery (LMWH, UFH)
diagnosis of preeclampsia (ISSHP classification , eclampsia or HELLP syndrome),
known history of deep vein thrombosis or pulmonary embolism,
known diagnosis of bleeding disorder or thrombophilia,
Parallel
Fibrogammin
DrugFibrogammin is administered according to the Summary of product characteristics (SmPC) after measured blood loss exceeds 700 ml and bleeding is ongoing
Blood Loss during post partum hemorrhage
Measured blood loss, in ml
Outcome of postpartum hemorrhage
Composite of adverse maternal outcomes related to postpartum hemorrhage, including postpartum hemorrhage with measure blood loss ≥2000 mL (within 24 hours), admission to intensive care unit, blood transfusion, need for embolization of the pelvic arteries, laparotomy with surgical measures (such as compression sutures, or ligatures), or hysterectomy during hospitalization.
Changes in hematological standard value: hemoglobin
Comparison of hemoglobin values, pre-partum and post-partum (in g/L)
Changes in hematological standard value: leucocyte count
Comparison of leucocyte count, pre-partum and post-partum (in G/l)
Changes in hematological standard value; thrombocyte count
Comparison of thrombocyte count, pre-partum and post-partum (in G/l)
Thromboembolic events
Number of thromboembolic events (safety outcome)
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Christian Haslinger
Lead sponsor
University of Zurich
Sponsor institution
Swiss National Science Foundation
Collaborator
