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

Switzerland (ICTRP)

Identifiant de l'essai ICTRP
NCT06481995 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
Early factor XIII replacement in postpartum hemorrhage: multi-center, random-ized, controlled, investigator-initiated trial (BASEC)

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

Titre public
SWIFT - SWIss Factor XIII Trial in PPH (ICTRP)

Maladie en cours d'investigation
Postpartum HemorrhageCoagulation DisorderCoagulation Factor DeficiencyHemorrhagePostpartum Complication (ICTRP)

Intervention étudiée
Drug: Fibrogammin (ICTRP)

Type d'essai
Interventional (ICTRP)

Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). (ICTRP)

Critères d'inclusion/exclusion
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 disponible

Critères d'évaluation principaux et secondaires
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)

Date d'enregistrement
non disponible

Inclusion du premier participant
non disponible

Sponsors secondaires
Swiss National Science Foundation, Switzerland (ICTRP)

Contacts supplémentaires
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 secondaires
BASEC 2024 - 00374 (ICTRP)

Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06481995 (ICTRP)