SWIFT - SWIss Factor XIII Trial in PPH

NCT06481995 | Recruiting Phase 4 DMC

• 1 other identifier: BASEC 2024 - 00374
• Study Type: interventional
• Target: 988
• Locations: 1 country
• Sites: 9

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.

Conditions

Postpartum Hemorrhage; Coagulation Disorder; Coagulation Factor Deficiency; Hemorrhage; Postpartum Complication

Keywords

Postpartum hemorrhage; coagulation factor XIII

Outcome Measures

Primary Outcomes (1)

• Blood Loss during post partum hemorrhage

  Measured blood loss, in ml

  Day 1 (within 24 hours after delivery)

Secondary Outcomes (7)

• Outcome of postpartum hemorrhage

  Time point of assessment will be 48 hours (range 36 to 60) postpartum, if not stated otherwise

• Changes in hematological standard value: hemoglobin

  shortly before delivery and 48 hours (range 36 to 60 hours) after delivery

• Changes in hematological standard value: leucocyte count

  shortly before delivery and 48 hours (range 36 to 60 hours) after delivery

• Changes in hematological standard value; thrombocyte count

  shortly before delivery and 48 hours (range 36 to 60 hours) after delivery

• Hospital costs

  from admission to hospital until hospital discharge, up to 9 weeks

Other Outcomes (1)

• Thromboembolic events

  6 - 9 weeks after delivery (visit 4)

Study Arms (2)

Fibrogammin (FXIII)

EXPERIMENTAL

Women in the intervention group receive FXIII intravenously in addition to the standard of care treatment for PPH. FXIII is administered when blood loss is \> 700 ml. Women weighing \<80 kg receive 1250 IU Fibrogammin®; women weighing 80-99.9 kg receive 1500 IU Fibrogammin®; thus ensuring a dose of 15-20 IU FXIII per kg body weight according to the manufacturer's recommendation.

Drug: Fibrogammin

Control

NO INTERVENTION

Women in the control group will be treat according to the standard of care procedure for PPH.

Interventions

Fibrogammin DRUG

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

Also known as: Factor XIII

Fibrogammin (FXIII)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• planned vaginal delivery
• singleton vital pregnancy
• gestational age at delivery \>= 30+0 weeks
• maternal weight at admission for delivery \<100 kg

You may not qualify if:

• 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.
• 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),

Sponsors & Collaborators

• Christian Haslinger: lead
• Swiss National Science Foundation: collaborator

Study Sites (9)

University Hospital Geneva

Geneva, Canton of Geneva, 1205, Switzerland

NOT YET RECRUITING

Cantonal Hospital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

RECRUITING

Spital Zollikerberg

Zollikerberg, Canton of Zurich, 8125, Switzerland

RECRUITING

University Hospital of Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Cantonal Hospital Baden

Baden, 5404, Switzerland

RECRUITING

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Inselspital-University Hospital Bern

Bern, 3010, Switzerland

RECRUITING

University Hospital Lausanne

Lausanne, 1005, Switzerland

RECRUITING

Cantonal Hospital St. Gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

Related Publications (8)

• Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.

  PMID: 25103301 BACKGROUND

• GBD 2015 Maternal Mortality Collaborators. Global, regional, and national levels of maternal mortality, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1775-1812. doi: 10.1016/S0140-6736(16)31470-2. Erratum In: Lancet. 2017 Jan 7;389(10064):e1. doi: 10.1016/S0140-6736(16)32609-5.

  PMID: 27733286 BACKGROUND

• Weeks A. The prevention and treatment of postpartum haemorrhage: what do we know, and where do we go to next? BJOG. 2015 Jan;122(2):202-10. doi: 10.1111/1471-0528.13098. Epub 2014 Oct 7.

  PMID: 25289730 BACKGROUND

• WHO Recommendations for the Prevention and Treatment of Postpartum Haemorrhage. Geneva: World Health Organization; 2012. Available from http://www.ncbi.nlm.nih.gov/books/NBK131942/

  PMID: 23586122 BACKGROUND

• Korte WC, Szadkowski C, Gahler A, Gabi K, Kownacki E, Eder M, Degiacomi P, Zoller N, Devay J, Lange J, Schnider T. Factor XIII substitution in surgical cancer patients at high risk for intraoperative bleeding. Anesthesiology. 2009 Feb;110(2):239-45. doi: 10.1097/ALN.0b013e318194b21e.

  PMID: 19194150 BACKGROUND

• Wettstein P, Haeberli A, Stutz M, Rohner M, Corbetta C, Gabi K, Schnider T, Korte W. Decreased factor XIII availability for thrombin and early loss of clot firmness in patients with unexplained intraoperative bleeding. Anesth Analg. 2004 Nov;99(5):1564-1569. doi: 10.1213/01.ANE.0000134800.46276.21.

  PMID: 15502066 BACKGROUND

• Haslinger C, Korte W, Hothorn T, Brun R, Greenberg C, Zimmermann R. The impact of prepartum factor XIII activity on postpartum blood loss. J Thromb Haemost. 2020 Jun;18(6):1310-1319. doi: 10.1111/jth.14795. Epub 2020 Apr 16.

  PMID: 32176833 RESULT

• Haslinger C, Hothorn T, Bossung V, Kalimeris S, Ranieri E, Ochsenbein-Koelble N, Korte W. Effects of early factor XIII replacement in postpartum hae morrhage: study protocol for a multicentre, open-label, randomised, controlled, investigator-initiated trial. BMJ Open. 2025 May 8;15(5):e100262. doi: 10.1136/bmjopen-2025-100262.

  PMID: 40345697 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage; Hemostatic Disorders; Hemorrhage

Interventions

Fibrinolysin; Factor XIII

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Enzyme Precursors; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Christian Haslinger, Prof. Dr.

  University of Zurich

  STUDY CHAIR

• Sara de Oliveira, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

• Hélène Legardeur, MD

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

• Beatrice Mosimann, Prof. Dr.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Tina Fischer, MD

  HOCH Health Ostschweiz

  PRINCIPAL INVESTIGATOR

• Leonhard Schäffer, Prof. Dr.

  Kantonsspital Baden

  PRINCIPAL INVESTIGATOR

• Michael Winter, MD

  Spital Zollikerberg

  PRINCIPAL INVESTIGATOR

• Jarmila Zdanowicz, MD

  Inselspital-University Hospital Bern

  PRINCIPAL INVESTIGATOR

• Leila Sultan-Beyer, MD

  Cantonal Hospital Winterthur

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Haslinger, Prof. Dr

CONTACT

0041 432537575; Christian.haslinger@usz.ch

Annick Toggenburger, PhD

CONTACT

annick.toggenburger-schroeder@usz.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The analysis of the primary outcome will be performed using blinded treatment arms.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Christian Haslinger

Model Details: multi- center, randomized, controlled

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: July 1, 2024
• Study Start: July 9, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: At the time of publication
• Access Criteria: Access will be provided without limitations. Data will be provided to allow independent computational reproducibility of already published results.

Locations

CH (9)