Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage: A Randomised Clinically Controlled Trial
Information source: Copenhagen University Hospital at Herlev
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postpartum Haemorrhage
Intervention: Fibrinogen Concentrate (Drug); Isotonic Saline (Drug)
Phase: Phase 2/Phase 3
Sponsored by: Copenhagen University Hospital at Herlev
Official(s) and/or principal investigator(s):
Anne J. Wikkelsoe, MD, Principal Investigator, Affiliation: Department of Anaesthesiology, University Hospital of Herlev, Denmark
Ann M. Møller, MD, DmSc, Study Chair, Affiliation: Department of Anaesthesiology, University Hospital of Herlev, Denmark
Jakob Stensballe, MD, PhD, Study Chair, Affiliation: Blood Bank of Danish Capital Region, Rigshospitalet
Jens Langhoff-Roos, MD, DmSc, Study Chair, Affiliation: Department of Obstetrics, Juliane Marie Centre, Rigshospitalet
Arash Afshari, MD, Study Chair, Affiliation: Department of Anaesthesiology, Juliane Marie Centre, Rigshospitalet, Denmark
Hellen McKinnon Edwards, M.D., Study Chair, Affiliation: Dep. of Anaesthesiology, Herlev
Severe maternal bleeding is a serious complication of birth and causes 125. 000 deaths
worldwide each year. The investigators aim to investigate if early treatment with fibrinogen
concentrate versus saline can reduce the incidence of blood transfusion in women with
A low level of fibrinogen has been associated with increased blood loss and transfusion
requirements in different clinical settings including obstetrical bleeding. Early up-front
treatment with fibrinogen may reduce incidence of transfusion by securing optimal
haemostatic capacity in women with postpartum haemorrhage.
The investigators plan to enrol 245 patients on four hospitals in the Capital Region of
Denmark during a two year period.
As safety measure the investigators plan to use TEG®/Functional Fibrinogen/Rapid-TEG as
haemostatic monitoring of all participants during the trial: Baseline test is taken at
inclusion before administration of fibrinogen concentrate/placebo. Further tests are taken
immediately after intervention, 4 hours and 24 hours after. Baseline test is blinded to the
providers of treatment - the rest is clinically available.
Official title: Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage - A Randomised Clinically Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Incidense of transfusion with allogenic blood products
Severe Postpartum Haemorrhage (PPH)
Estimated blood loss
Total amount of blood transfused
The development of re-bleeding
Hemoglobin level below 3,6 mmol/L
Side-effects including thromboembolic complications
Experimental design Design: We plan to conduct a randomised double-blinded clinically
controlled trial: The participants are assigned to either 1) placebo (100 ml of isotonic
saline) i. v. or 2) the intervention drug: 2 g of fibrinogen concentrate (Haemocomplettan,
CSL Behring) i. v. We intend to use a fixed dose for all patients randomized to the
intervention group without prior measurement of the fibrinogen level. This strategy is
primarily based on the clinical urgency since the treatment is required to be administered
as early as possible.
Materials and duration of study Patients will be included during a two year period at the
four largest hospitals in the Capital Region: Rigshospitalet, Hvidovre, Hillerød and Herlev
if they fulfil the following eligibility criteria Plan of trial execution In order to secure
the ethical aspect "Time for reflection" we will provide all pregnant women who appear in
the centres during the trial period with written information on the trial during their
midwife evaluation. Only 1,75% of these women are estimated to meet the inclusion criteria
Intensive haemostatic monitoring Haemostatic blood samples including thrombelastography
(TEG®), functional fibrinogen-assay for TEG®, Rapid-TEG, fibrinogen-level, d-Dimer, INR
(international normalized ratio), platelet count and Antithrombin III will be drawn 15
minutes after the intervention is given, 4 hours and 24 hours later. The samples taken after
the intervention are fully available for evaluation by the clinicians responsible for the
patient. The patient will be observed with blood pressure, pulseoximetry, ECG and possible
side effects or re-bleeding will be evaluated.
Follow up The patients will remain hospitalized for a minimum of 24 hours. We will contact
all participants by phone six weeks after the intervention. Upon discharge from the
hospital, all included patients receive information-material addressing possible late side
effects and a contact number.
Minimum age: 18 Years.
Maximum age: N/A.
1. Informed consent from participant.
2. Women who develop PPH defined as bleeding from uterus and/or the birth canal within
24 hours postpartum.
3. Age ≥ 18 years.
4. If vaginal birth: indication of one of the following procedures at the operation
theatre with anaesthetic assistance: a) Estimated blood loss ≥ 500 ml and indication
of manual removal of placenta or b) Indication of manual exploration of the uterus
due to continuous bleeding after the birth of placenta.
5. If birth by Caesarean section: A perioperative blood loss ≥ 1000 ml.
1. Patients with known inherited deficiencies of coagulation.
2. Patients in anti-thrombotic treatment prepartum due to increased risk of thrombosis.
3. Patients with a pre-pregnancy weight <45 kg.
4. Patients who refuse to receive blood transfusion.
Locations and Contacts
Juliane Marie Centre, Rigshospitalet, Copenhagen, Capital Region 2100, Denmark
University Hospital of Herlev, Herlev, Capital Region 2730, Denmark
University Hospital of Hilleroed, Hilleroed, Capital Region 3400, Denmark
University Hospital of Hvidovre, Hvidovre, Capital Region 2650, Denmark
Trial website - information for potential patients entering the study during post delivery phase and information for staff at trial sites. (In danish only)
Starting date: May 2011
Last updated: September 19, 2013