NCT06481995 SWIFT - SWIss Factor XIII Trial in PPH
| NCT ID | NCT06481995 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Christian Haslinger |
| Condition | Postpartum Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 988 participants |
| Start Date | 2024-07-09 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 988 participants in total. It began in 2024-07-09 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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),
Contact & Investigator
Christian Haslinger, Prof. Dr.
STUDY CHAIR
University of Zurich
Frequently Asked Questions
Who can join the NCT06481995 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Postpartum Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06481995 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06481995 currently recruiting?
Yes, NCT06481995 is actively recruiting participants. Contact the research team at Christian.haslinger@usz.ch for enrollment information.
Where is the NCT06481995 trial being conducted?
This trial is being conducted at Geneva, Switzerland, Winterthur, Switzerland, Zollikerberg, Switzerland, Zurich, Switzerland and 5 additional locations.
Who is sponsoring the NCT06481995 clinical trial?
NCT06481995 is sponsored by Christian Haslinger. The principal investigator is Christian Haslinger, Prof. Dr. at University of Zurich. The trial plans to enroll 988 participants.