Postpartum Haemorrhage Clinical Trial
Official title:
Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage - A Randomised Clinically Controlled Trial
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
postpartum haemorrhage.
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.
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
postpartum.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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