SWIFT - SWIss Factor XIII Trial in PPH
Early Factor XIII Replacement in Postpartum Hemorrhage: Multi-center, Randomized, Controlled, Investigator-initiated Trial
Christian Haslinger
988 participants
Jul 9, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- planned vaginal delivery
- singleton vital pregnancy
- gestational age at delivery \>= 30+0 weeks
- maternal weight at admission for delivery \<100 kg
Exclusion Criteria15
- 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,
- known thrombocytopenia during second half of pregnancy with thrombocytes \< 100 G/L,
- known anemia during second half of pregnancy with Hb\<80 g/L,
- known sickle cell disease,
- known malignant tumor(s),
- participation in another study with investigational drug within the 30 days preceding and during the present study,
- inability to follow the procedures of the study, e.g. due to language problems,
- known or suspected non-compliance, drug or alcohol abuse.
- Maternal fever ≥39.0°C
- unplanned cesarean delivery is performed,
- Measured Blood Loss remains \< 700 mL after administration of 1g tranexamic acid .
- Postpartum hemorrhage due to occult bleeding (intra-abdominal, retroperitoneal, parametric),
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Fibrogammin is administered according to the Summary of product characteristics (SmPC) after measured blood loss exceeds 700 ml and bleeding is ongoing
Locations(9)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06481995