SWIFT - SWIss Factor XIII Trial in PPH

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.

Conditions

• Postpartum Hemorrhage
• Coagulation Disorder
• Coagulation Factor Deficiency
• Hemorrhage
• Postpartum Complication

Interventions

DRUG

Fibrogammin

Fibrogammin is administered according to the Summary of product characteristics (SmPC) after measured blood loss exceeds 700 ml and bleeding is ongoing

Sponsors & Collaborators

• Swiss National Science Foundation

  collaborator OTHER

• Christian Haslinger

  lead OTHER

Principal Investigators

• Christian Haslinger, Prof. Dr. · University of Zurich

• Sara de Oliveira, MD · University Hospital, Geneva

• Hélène Legardeur, MD · University of Lausanne Hospitals

• Beatrice Mosimann, Prof. Dr. · University Hospital, Basel, Switzerland

• Tina Fischer, MD · HOCH Health Ostschweiz

• Leonhard Schäffer, Prof. Dr. · Kantonsspital Baden

• Michael Winter, MD · Spital Zollikerberg

• Jarmila Zdanowicz, MD · Inselspital-University Hospital Bern

• Leila Sultan-Beyer, MD · Cantonal Hospital Winterthur

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-09

Primary Completion

2028-06-30

Completion

2028-12-31

Countries

• Switzerland

Study Locations