Influence of the coagulation factor (factor 13) in severe bleeding after childbirth
Zusammenfassung der Studie
Increased bleeding after childbirth occurs more frequently than generally assumed (about one in four women bleeds more than half a liter after vaginal births). Severe bleeding is rarer (about 7% bleed more than one liter after a vaginal birth) and often unpredictable, but it can lead to an emergency situation. Worldwide, including in Switzerland, we observe an increase in severe and critical bleeding after childbirth, with a corresponding rise in associated complications. Today, in addition to the measures taken by obstetricians, medications, coagulation factors, and finally blood transfusions are available as therapy. This aims to stop the bleeding and replace the blood loss. In earlier published studies, a strong correlation between a coagulation factor (factor 13) and postpartum blood loss has been demonstrated. In this study, we investigate the next logical step, whether the use of coagulation factor 13 as a short infusion into a vein at an earlier point of bleeding than usual actually helps to reduce blood loss and effectively avoid further complications associated with bleeding. Furthermore, we investigate which coagulation factors are significant before and after childbirth.
(BASEC)
Untersuchte Intervention
Administration of Fibrogammin (coagulation factor 13)
(BASEC)
Untersuchte Krankheit(en)
Severe bleeding after childbirth
(BASEC)
Pregnant women aged 18 and over who come to the hospital for delivery. (BASEC)
Ausschlusskriterien
Women with planned cesarean sections, multiple pregnancies, or known coagulation disorders are excluded from the study. (BASEC)
Studienstandort
Aarau, Basel, Bern, Genf, Lausanne, St Gallen, Winterthur, Zürich, Andere
(BASEC)
Zollikerberg
(BASEC)
Sponsor
Prof. Dr. med. Christian Haslinger
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Christian Haslinger
+41 44 255 11 11
swift@clutterusz.chUniversitätsspital Zürich
(BASEC)
Allgemeine Auskünfte
University of Zurich,University Hospital, Geneva,University of Lausanne Hospitals,University Hospital, Basel, Switzerland,Cantonal Hospital St. Gallen,Kantonsspital Baden,Spital Zollikerberg,Inselspital-University Hospital Bern,Cantonal Hospital Winterthur,
0041 432537575
swift@clutterusz.ch(ICTRP)
Allgemeine Auskünfte
University of ZurichUniversity Hospital, GenevaUniversity of Lausanne HospitalsUniversity Hospital, Basel, SwitzerlandCantonal Hospital St. GallenKantonsspital BadenSpital ZollikerbergInselspital-University Hospital BernCantonal Hospital Winterthur
0041 432537575
swift@clutterusz.ch(ICTRP)
Wissenschaftliche Auskünfte
University of Zurich,University Hospital, Geneva,University of Lausanne Hospitals,University Hospital, Basel, Switzerland,Cantonal Hospital St. Gallen,Kantonsspital Baden,Spital Zollikerberg,Inselspital-University Hospital Bern,Cantonal Hospital Winterthur,
0041 432537575
swift@clutterusz.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
14.06.2024
(BASEC)
ICTRP Studien-ID
NCT06481995 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Early factor XIII replacement in postpartum hemorrhage: multi-center, random-ized, controlled, investigator-initiated trial (BASEC)
Wissenschaftlicher Titel
Early Factor XIII Replacement in Postpartum Hemorrhage: Multi-center, Randomized, Controlled, Investigator-initiated Trial (ICTRP)
Öffentlicher Titel
SWIFT - SWIss Factor XIII Trial in PPH (ICTRP)
Untersuchte Krankheit(en)
Postpartum HemorrhageCoagulation DisorderCoagulation Factor DeficiencyHemorrhagePostpartum Complication (ICTRP)
Untersuchte Intervention
Drug: Fibrogammin (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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 =39.0C
- 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), (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Blood Loss during post partum hemorrhage (ICTRP)
Outcome of postpartum hemorrhage;Changes in hematological standard value: hemoglobin;Changes in hematological standard value: leucocyte count;Changes in hematological standard value; thrombocyte count;Hospital costs;Breastfeeding;Patient survey (in a subgroup of patients only) (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Swiss National Science Foundation, Switzerland (ICTRP)
Weitere Kontakte
Christian Haslinger, Prof. Dr.;Bego?a Martinez de Tejada, MD PhD;David Baud, MD PhD;Beatrice Mosimann, Prof. Dr.;Tina Fischer, MD;Leonhard Sch?ffer, Prof. Dr.;Michael Winter, MD;Jarmila Zdanowicz, MD;Leila Sultan-Beyer, MD;Christian Haslinger, Prof. Dr, Christian.haslinger@usz.ch, 0041 432537575, University of Zurich,University Hospital, Geneva,University of Lausanne Hospitals,University Hospital, Basel, Switzerland,Cantonal Hospital St. Gallen,Kantonsspital Baden,Spital Zollikerberg,Inselspital-University Hospital Bern,Cantonal Hospital Winterthur, (ICTRP)
Sekundäre IDs
BASEC 2024 - 00374 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06481995 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar