Postpartum Haemorrhage Clinical Trial
Official title:
Use of Prothrombin Complex Concentrate and Fibrinogen Compared With Fresh Frozen Plasma (and Fibrinogen if Needed) in the Treatment of Postpartum Haemorrhage
The purpose of the study is to find out if the regimen of prothrombin complex concentrate (PCC) together with fibrinogen concentrate is as efficient as fresh frozen plasma (FFP) (plus fibrinogen if needed) during the early stages of the transfusion therapy in postpartum haemorrhage (PPH). The original protocol included the use of HES and the recruitment of patients was postponed while waiting the final decision by EMA. All HES solutions were abandoned at our institution in September and an amendment was made to change the protocol. HES solution are replaced by the use of hyperoncotic (20%) albumin.
Forty patients are randomized to receive either PCC and fibrinogen concentrate (PCC group) or
FFP (and fibrinogen if needed) (FFP group), 20 patients in each group. Patients in the PCC
group receive 15 IU/kg of PCC concentrate and 2 g of fibrinogen concentrate. Patients in the
FFP group receive 4 units of FFP. In both groups, additional fibrinogen is administered (if
needed) to increase the baseline FIBTEM-MCF (at 5 min) to the target of 15 mm.
Baseline blood samples will be drawn at study inclusion when the (on-going) blood loss
exceeds 1500 ml. The next samples will be drawn at 45 min (or immediately after the
administration of the study drug if later). Otherwise, the management protocol strictly
follows the local PPH guideline.
The primary endpoint is the amount of blood loss within the first 6 and 24 hours after
delivery. Secondary endpoints include the difference/similarity in the laboratory
determinations (ia coagulation screen, PFA-100, CAT and ROTEM).
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