PCC and Fibrinogen Compared With FFP in PPH

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Postpartum Haemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PCC group

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.

Group Type EXPERIMENTAL

PCC

Intervention Type DRUG

15 IU/kg Octaplex and 2 g Riastab. Additional fibrinogen if needed.

FFP group

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).

Group Type ACTIVE_COMPARATOR

FFP

Intervention Type DRUG

4 units Octaplas. Additional fibrinogen if needed.

Interventions

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PCC

15 IU/kg Octaplex and 2 g Riastab. Additional fibrinogen if needed.

Intervention Type DRUG

FFP

4 units Octaplas. Additional fibrinogen if needed.

Intervention Type DRUG

Other Intervention Names

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Octaplex, Riastab Octaplas

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No