Study Results
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Basic Information
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RECRUITING
PHASE4
988 participants
INTERVENTIONAL
2024-07-09
2028-12-31
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Fibrogammin (FXIII)
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.
Fibrogammin
Fibrogammin is administered according to the Summary of product characteristics (SmPC) after measured blood loss exceeds 700 ml and bleeding is ongoing
Control
Women in the control group will be treat according to the standard of care procedure for PPH.
No interventions assigned to this group
Interventions
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Fibrogammin
Fibrogammin is administered according to the Summary of product characteristics (SmPC) after measured blood loss exceeds 700 ml and bleeding is ongoing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* singleton vital pregnancy
* gestational age at delivery \>= 30+0 weeks
* maternal weight at admission for delivery \<100 kg
Exclusion Criteria
* 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),
18 Years
FEMALE
No
Sponsors
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Swiss National Science Foundation, Switzerland
UNKNOWN
Christian Haslinger
OTHER
Responsible Party
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Christian Haslinger
Prof. Dr. med. Christian Haslinger
Principal Investigators
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Christian Haslinger, Prof. Dr.
Role: STUDY_CHAIR
University of Zurich
Begoña Martinez de Tejada, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Geneva
David Baud, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Lausanne Hospitals
Beatrice Mosimann, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Tina Fischer, MD
Role: PRINCIPAL_INVESTIGATOR
Cantonal Hospital St. Gallen
Leonhard Schäffer, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Kantonsspital Baden
Michael Winter, MD
Role: PRINCIPAL_INVESTIGATOR
Spital Zollikerberg
Jarmila Zdanowicz, MD
Role: PRINCIPAL_INVESTIGATOR
Inselspital-University Hospital Bern
Leila Sultan-Beyer, MD
Role: PRINCIPAL_INVESTIGATOR
Cantonal Hospital Winterthur
Locations
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University Hospital Geneva
Geneva, Canton of Geneva, Switzerland
Cantonal Hospital Winterthur
Winterthur, Canton of Zurich, Switzerland
Spital Zollikerberg
Zollikerberg, Canton of Zurich, Switzerland
University Hospital of Zurich
Zurich, Canton of Zurich, Switzerland
Cantonal Hospital Baden
Baden, , Switzerland
University Hospital Basel
Basel, , Switzerland
Inselspital-University Hospital Bern
Bern, , Switzerland
University Hospital Lausanne
Lausanne, , Switzerland
Cantonal Hospital St. Gallen
Sankt Gallen, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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/
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.
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.
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.
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.
Other Identifiers
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BASEC 2024 - 00374
Identifier Type: -
Identifier Source: org_study_id
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