Condition: Postpartum Hemorrhage · Coagulation Disorder · Coagulation Factor Deficiency · Sponsor: Christian Haslinger
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.
This description comes directly from the study's public registry record.
Christian Haslinger, Prof. Dr · 0041 432537575 · Christian.haslinger@usz.ch
Annick Toggenburger, PhD · annick.toggenburger-schroeder@usz.ch
Always discuss trial participation with your own doctor first.
| University Hospital Geneva | Geneva, Canton of Geneva, Switzerland | Not Yet Recruiting |
| Cantonal Hospital Winterthur | Winterthur, Canton of Zurich, Switzerland | Recruiting |
| Spital Zollikerberg | Zollikerberg, Canton of Zurich, Switzerland | Recruiting |
| University Hospital of Zurich | Zurich, Canton of Zurich, Switzerland | Recruiting |
| Cantonal Hospital Baden | Baden, Switzerland | Recruiting |
| University Hospital Basel | Basel, Switzerland | Recruiting |
| Inselspital-University Hospital Bern | Bern, Switzerland | Recruiting |
| University Hospital Lausanne | Lausanne, Switzerland | Recruiting |
| Cantonal Hospital St. Gallen | Sankt Gallen, Switzerland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06481995