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SWIFT - SWIss Factor XIII Trial in PPH

RecruitingPhase 4Ages 18 Years - anyFemaleChristian Haslinger
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * planned vaginal delivery * singleton vital pregnancy * gestational age at delivery \>= 30+0 weeks * maternal weight at admission for delivery \<100 kg Exclusion Criteria: * 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. Exclusion criteria prior randomization * Maternal fever โ‰ฅ39.0ยฐC * 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),
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What it tests

  • Fibrogammin
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Where

9 sites
University Hospital Geneva
Geneva, Switzerland
Cantonal Hospital Winterthur
Winterthur, Switzerland
Spital Zollikerberg
Zollikerberg, Switzerland
University Hospital of Zurich
Zurich, Switzerland
Cantonal Hospital Baden
Baden, Switzerland
University Hospital Basel
Basel, Switzerland
Inselspital-University Hospital Bern
Bern, Switzerland
University Hospital Lausanne
Lausanne, Switzerland

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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