A Phase 4 interventional study of Fibrogammin in Postpartum Hemorrhage, Coagulation Disorder and Coagulation Factor Deficiency, sponsored by Christian Haslinger. Recruiting at 9 sites in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Christian Haslinger · Phase 4, Interventional, and Treatment
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:
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.
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
469 studies on the registry are indexed under Postpartum Hemorrhage; 76 are open to participants now.
This study's planned enrollment of 988 is above the median of 148 across 360 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Christian Haslinger is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria prior randomization
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Women in the control group will be treat according to the standard of care procedure for PPH.
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
Blood Loss during post partum hemorrhage
Measured blood loss, in ml
Time frame: Day 1 (within 24 hours after delivery)
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.
Time frame: Time point of assessment will be 48 hours (range 36 to 60) postpartum, if not stated otherwise
Changes in hematological standard value: hemoglobin
Comparison of hemoglobin values, pre-partum and post-partum (in g/L)
Time frame: shortly before delivery and 48 hours (range 36 to 60 hours) after delivery
Changes in hematological standard value: leucocyte count
Comparison of leucocyte count, pre-partum and post-partum (in G/l)
Time frame: shortly before delivery and 48 hours (range 36 to 60 hours) after delivery
Changes in hematological standard value; thrombocyte count
Comparison of thrombocyte count, pre-partum and post-partum (in G/l)
Time frame: shortly before delivery and 48 hours (range 36 to 60 hours) after delivery
Hospital costs
Total costs (in CHF)
Time frame: from admission to hospital until hospital discharge, up to 9 weeks
Breastfeeding
Number of women who exclusively breastfeed their babies after PPH
Time frame: 6 - 9 weeks after delivery
Patient survey (in a subgroup of patients only)
Questionnaire for personal experience during PPH
Time frame: discharge from hospital, estimated 3 - 5 days after delivery
Thromboembolic events
Number of thromboembolic events (safety outcome)
Time frame: 6 - 9 weeks after delivery (visit 4)
Plan to share: 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).
Supporting information: Study protocol, Informed consent form, 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.
Started Jul 2024 (actual). Primary completion is estimated for Jun 2028, 47 months after the start.
Of 27 non-industry phase 4 interventional studies under Postpartum Hemorrhage, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 20. This study's planned 47 months is above that.
Counting every sponsor, half of 28 studies reached it within 12 months; a quarter within 10 and three quarters within 20.
How these figures are worked out, and which studies are left out of them.
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Christian Haslinger