Clinical trial NCT01910675: PCC and Fibrinogen Compared With FFP in PPH
Official title: Use of Prothrombin Complex Concentrate and Fibrinogen Compared With Fresh Frozen Plasma (and Fibrinogen if Needed) in the Treatment of Postpartum Haemorrhage
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Postpartum Haemorrhage
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

Women who have delivered vaginally or by caesarean section with a PPH of 2000 ml (the amount of blood loss: in addition to the suctioned blood, sponges, wraps, swabs, etc. are carefully weighed)

Exclusion Criteria:

Women with a history of bleeding tendency or hepatic or renal insufficiency, or PPH exceeding 3000 ml because in that case the initial need for fibrinogen may be even more

Primary outcomes:
measure: Blood loss
timeFrame: Within the first 6 and 24 hours after delivery
Secondary outcomes:
measure: Maximum clot firmness (MCF)
timeFrame: At the time when the blood loss exceeds 1500 ml and 45 min later
measure: Endogenous thrombin potential
timeFrame: At the time when the blood loss exceeds 1500 ml and 45 min later
measure: Fibrinogen level
timeFrame: At the time when the blood loss exceeds 1500 ml and 45 min later
measure: Platelet function
timeFrame: At the time when the blood loss exceeds 1500 ml and 45 min later
measure: Clotting time (CT)
timeFrame: At the time when the blood loss exceeds 1500 ml and 45 min later
measure: Clot formation time (CFT)
timeFrame: At the time when the blood loss exceeds 1500 ml and 45 min later
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Maternity Hospital, Helsinki University Central Hospital
state: Uusimaa
Study officials:
affiliation: Maternity Hospital, Helsinki University Central Hospital
name: Jouni V. Ahonen, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahonen J, Stefanovic V, Lassila R. Management of post-partum haemorrhage. Acta Anaesthesiol Scand. 2010 Nov;54(10):1164-78. doi: 10.1111/j.1399-6576.2010.02309.x.