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Postpartum HemorrhagePhase 4SWIFTNCT06481995

SWIFT - SWIss Factor XIII Trial in PPH

A Phase 4 study testing Fibrogammin in people with Postpartum Hemorrhage and Coagulation Disorder, run by Christian Haslinger at 9 sites in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Fibrogammin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
988 participants
Where
9 sitesSwitzerland
Study dates
9 Jul 2024to 31 Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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,
Show all 15Show fewer
  • 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),

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Christian Haslinger, Prof. Dr contact

0041 432537575

Christian.haslinger@usz.ch

Annick Toggenburger, PhD contact

annick.toggenburger-schroeder@usz.ch

9 sites in 1 country

Switzerland9 sites, 9 recruiting

  • Cantonal Hospital Baden

    Baden, 5404

    Leonhard Schäffer, Prof. Dr., Leonhard.Schaeffer@ksb.ch

    Recruiting

  • University Hospital Basel

    Basel, 4031

    Beatrice Mosimann, Prof. Dr., beatrice.mosimann@usb.ch

    Recruiting

  • Inselspital-University Hospital Bern

    Bern, 3010

    Jarmila Zdanowicz, jarmila.zdanowicz@insel.ch

    Recruiting

  • University Hospital Geneva

    Geneva, Canton of Geneva, 1205

    Begoña Martinez de Tejada, MD PhD, begona.martinezdetejada@hcuge.ch

    Not yet recruiting

  • University Hospital Lausanne

    Lausanne, 1005

    David Baud, MD PhD, david.baud@chuv.ch

    Helene Legardeur, helene.legardeur@chuv.ch

    Recruiting

  • Cantonal Hospital St. Gallen

    Sankt Gallen, 9007

    Tina Fischer, MD, tina.fischer@kssg.ch

    Recruiting

  • Cantonal Hospital Winterthur

    Winterthur, Canton of Zurich, 8401

    Leila Sultan-Beyer, MD, leila.sultan-beyer@ksw.ch

    Recruiting

  • Spital Zollikerberg

    Zollikerberg, Canton of Zurich, 8125

    Michael Winter, MD, michael.winter@spitalzollikerberg.ch

    Recruiting

  • University Hospital of Zurich

    Zurich, Canton of Zurich, 8091

    Christian Haslinger, Prof. Dr., 0041 432537575, Christian.haslinger@usz.ch

    Annick Toggenburger, PhD, annick.toggenburger-schroeder@usz.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Early Factor XIII Replacement in Postpartum Hemorrhage: Multi-center, Randomized, Controlled, Investigator-initiated Trial

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:

Read more
  • 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.

Read the detailed description

Postpartum hemorrhage (PPH) is a main reason for maternal mortality and morbidity. PPH, defined by the WHO as blood loss of 500 mL or more within 24 hours after delivery, causes about 30% of maternal deaths worldwide. The internationally observed trend towards increased PPH-related morbidity and mortality is disturbing and demands new strategies in the prevention and treatment of PPH.

Although the most frequent causes for severe PPH are believed to be uterine atony or retained placenta, virtually all cases of severe PPH lead to a disorder of the coagulation system which itself aggravates bleeding.

At the moment, most guidelines on coagulation management during PPH and expert opinions focus on the replenishment of coagulation factor I (fibrinogen) although three out of three randomized controlled trials with early or pre-emptive administration of fibrinogen during PPH were negative.

Based on earlier research, it was hypothesized that coagulation factor XIII (FXIII) might play a significant role in women with increased postpartum blood loss, because of its role in the establishment of blood clot stability and fibrinolytic resistance. This hypothesis was tested in a prospective diagnostic study involving 1300 parturient women at the University Hospital Zurich and showed that pre-partum factor XIII activity had a strong association to postpartum blood loss.

Therefore, this nationwide, multi-center, open-label, randomized controlled trial in major perinatal centers across Switzerland will be conducted. The goal is to determine if postpartum blood loss and PPH-related complications can be reduced by substitution of FXIII at an early stage of PPH.

Irrespective of the answer to the question whether FXIII is effective in the treatment of PPH, this trial will contribute to enhancing the comprehension of coagulopathy in the context of PPH

Being tested
Fibrogammin
Keywords
Postpartum hemorrhage, coagulation factor XIII
Medical subject headings
Postpartum Hemorrhage, Hemostatic Disorders, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FibrogamminDrug

    Also called Factor XIII

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

Study groups in NCT06481995
Study groupRoleWhat they receive
Fibrogammin (FXIII)ExperimentalWomen 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.
Receives: Drug: Fibrogammin
ControlNo interventionWomen in the control group will be treat according to the standard of care procedure for PPH.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Loss during post partum hemorrhage

    Measured blood loss, in ml

    Measured: Day 1 (within 24 hours after delivery)

Secondary outcomes (7)

  1. Outcome of postpartum hemorrhage

    Composite of adverse maternal outcomes related to postpartum hemorrhage, including postpartum hemorrhage with measure blood loss ≥2000 mL (within 24 hours), admission to intensive care unit, blood transfusion, need for embolization of the pelvic arteries, laparotomy with surgical measures (such as compression sutures, or ligatures), or hysterectomy during hospitalization.

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

  2. Changes in hematological standard value: hemoglobin

    Comparison of hemoglobin values, pre-partum and post-partum (in g/L)

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

  3. Changes in hematological standard value: leucocyte count

    Comparison of leucocyte count, pre-partum and post-partum (in G/l)

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

  4. Changes in hematological standard value; thrombocyte count

    Comparison of thrombocyte count, pre-partum and post-partum (in G/l)

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

  5. Hospital costs

    Total costs (in CHF)

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

  6. Breastfeeding

    Number of women who exclusively breastfeed their babies after PPH

    Measured: 6 - 9 weeks after delivery

  7. Patient survey (in a subgroup of patients only)

    Questionnaire for personal experience during PPH

    Measured: discharge from hospital, estimated 3 - 5 days after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2024
  2. Study start9 Jul 2024
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
multi- center, randomized, controlled
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
988 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06481995
Sponsor's protocol ID
BASEC 2024 - 00374
Acronym
SWIFT
Status last verified
Apr 2026
First submitted
31 May 2024
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data sharing plan aims to ensure computational reproducibility of all published research findings obtained from data collected in this trial. Each publication will be accompanied by a dedicated compendium containing deidentified individual patient data necessary to independently reproduce the analyses presented in the corresponding publication. Such a compendium also contains information about the computer code that was used to generate figures, tables, and other statistical output. Distribution will be via a data repository following FAIR principles (such as zenodo.org).

Publications

  • 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.

    PubMed 25103301

  • 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.

    PubMed 27733286

  • 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.

    PubMed 25289730

  • 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/

    PubMed 23586122

  • 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.

    PubMed 19194150

  • 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.

    PubMed 15502066

  • 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.

    PubMed 32176833

  • Jacobs JW, Abels EA, Adkins BD, Booth GS, Costa V, Raza S, Simon M, Woo JS, Wheeler AP. Factor XIII Supplementation in Postpartum Hemorrhage: From Biological Rationale to Clinical Implementation. Am J Hematol. 2026 Apr;101(4):794-806. doi: 10.1002/ajh.70181. Epub 2025 Dec 31.

    PubMed 41472522

  • 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.

    PubMed 40345697

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fibrogammin in people with Postpartum Hemorrhage and Coagulation Disorder, run by Christian Haslinger at 9 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christian Haslinger, Prof. Dr (0041 432537575, Christian.haslinger@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Loss during post partum hemorrhage (time frame: Day 1 (within 24 hours after delivery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06481995, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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