SWIFT - SWIss Factor XIII Trial in PPH
NCT Number: NCT06481995
Acronym: SWIFT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Postpartum Hemorrhage|Coagulation Disorder|Coagulation Factor Deficiency|Hemorrhage|Postpartum Complication
Interventions: DRUG: Fibrogammin
Sponsor: University of Zurich
Collaborators: University Hospital, Geneva|Centre Hospitalier Universitaire Vaudois|University of Basel|Cantonal Hospital of St. Gallen|Kantonsspital Baden|Spital Zollikerberg|Insel Gruppe AG, University Hospital Bern|Kantonsspital Winterthur KSW
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 988
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-09
Completion Date: 2028-12-31
Locations: Cantonal Hospital Winterthur, Winterthur, Zurich, 8401, Switzerland|Spital Zollikerberg, Zollikerberg, Zurich, 8125, Switzerland|Cantonal Hospital Baden, Baden, 5404, Switzerland|University Hospital Basel, Basel, 4031, Switzerland|Inselspital Bern, Bern, 3010, Switzerland|University Hospital Geneva, Genève, 1205, Switzerland|University Hospital Lausanne, Lausanne, 1005, Switzerland|Cantonal Hospital St. Gallen, Saint Gallen, 9007, Switzerland|University Hospital of Zurich, Zurich, 8091, Switzerland

Summary:
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.

Primary Outcome Measures: Blood Loss during post partum hemorrhage, Measured blood loss, in ml, Day 1 (within 24 hours after delivery)
Secondary Outcome Measures: Outcome of postpartum hemorrhage, Number of adverse maternal outcomes related to postpartum hemorrhage, such as Postpartum hemorrhage with measure blood loss ≥2000 mL, admission to intensive care unit, blood transfusion, need for embolization of the pelvic arteries, laparotomy with surgical measures (such as compression sutures, ligatures), or hysterectomy, Day 1 (within 24 hours after delivery)|Changes in hematological standard value: hemoglobin, Comparison of hemoglobin values, pre-partum and post-partum (in g/L), shortly before delivery and 48 hours after delivery (visit 2)|Changes in hematological standard value: leucocyte count, Comparison of leucocyte count, pre-partum and post-partum (in G/l), shortly before delivery and 48 hours after delivery (visit 2)|Changes in hematological standard value; thrombocyte count, Comparison of thrombocyte count, pre-partum and post-partum (in G/l), shortly before delivery and 48 hours after delivery (visit 2)|Hospital costs, Total costs (in CHF), from admission to hospital until hospital discharge, up to 9 weeks|Breastfeeding, Number of women who exclusively breastfeed their babies after PPH, 6 - 9 weeks after delivery (visit 4)|Patient survey (in a subgroup of patients only), Questionnaire for personal experience during PPH, discharge from hospital, estimated 3 - 5 days after delivery
Other Outcome Measures: Thromboembolic events, Number of thromboembolic events (safety outcome), 6 - 9 weeks after delivery (visit 4)