PCC and Fibrinogen Compared With FFP in PPH

Helsinki University Central Hospital (HUCH)

Status and phase: Withdrawn; Phase 4

Conditions: Postpartum Haemorrhage

Treatments: Drug: FFP; Drug: PCC

Study type: Interventional

Funder types: Other

Identifiers

NCT01910675

EudraCT-2012-003128

U1030N7560 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

PCC group

Experimental group

Description:

Twenty patients in the PCC group receive 15 IU/kg of Octaplex concentrate and 2 g of Riastap concentrate. Additional fibrinogen is administered (if needed) to increase the baseline FIBTEM-MCF (at 5 min) to the target of 15 mm.

Treatment:

Drug: PCC

FFP group

Active Comparator group

Description:

Twenty patients in the FFP group receive 4 units of FFP (Octaplas). Additional fibrinogen (Riastab) is administered (if needed) to increase the baseline FIBTEM-MCF (at 5 min) to the target of 15 mm. The fibrinogen content of the FFP will be taken into consideration (2.1 g in 4 units of FFP).

Treatment:

Drug: FFP