RecruitingPhase 4

SWIFT - SWIss Factor XIII Trial in PPH

Switzerland988 participantsStarted 2024-07-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 ≥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),

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Blood Loss during post partum hemorrhage

Timeframe: Day 1 (within 24 hours after delivery)

Trial details

NCT IDNCT06481995

SponsorChristian Haslinger

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-30

Contact for this trial

Christian Haslinger, Prof. Dr

0041 432537575 Christian.haslinger@usz.ch

View on ClinicalTrials.gov More Postpartum Hemorrhage trials