Influence of the coagulation factor (factor 13) in severe bleeding after childbirth

Switzerland (ICTRP)

ID di studio ICTRP
NCT06481995 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Early factor XIII replacement in postpartum hemorrhage: multi-center, random-ized, controlled, investigator-initiated trial (BASEC)

Titolo accademico
Early Factor XIII Replacement in Postpartum Hemorrhage: Multi-center, Randomized, Controlled, Investigator-initiated Trial (ICTRP)

Titolo pubblico
SWIFT - SWIss Factor XIII Trial in PPH (ICTRP)

Malattie studiate
Postpartum HemorrhageCoagulation DisorderCoagulation Factor DeficiencyHemorrhagePostpartum Complication (ICTRP)

Intervento studiato
Drug: Fibrogammin (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)

Criteri di inclusione/esclusione
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)

non disponibile

Endpoint primari e secondari
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)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
Swiss National Science Foundation, Switzerland (ICTRP)

Contatti aggiuntivi
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)

ID secondari
BASEC 2024 - 00374 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06481995 (ICTRP)