PCC and Fibrinogen Compared With FFP in PPH

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01910675
• Other study ID #: EudraCT-2012-003128
• Secondary ID: U1030N7560
• Status: Withdrawn
• Phase: Phase 4
• Start date: July 2013
• Est. completion date: October 2018

Study information

• Verified date: October 2018
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Haemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• PCC
15 IU/kg Octaplex and 2 g Riastab. Additional fibrinogen if needed.
• FFP
4 units Octaplas. Additional fibrinogen if needed.

Locations

Country	Name	City	State
Finland	Maternity Hospital, Helsinki University Central Hospital	Helsinki	Uusimaa

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Ahonen J, Stefanovic V, Lassila R. Management of post-partum haemorrhage. Acta Anaesthesiol Scand. 2010 Nov;54(10):1164-78. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss	The suctioned blood is recorded and sponges, wraps, swabs, etc. are carefully weighed. The amount of blood loss will be compared between the groups.	Within the first 6 and 24 hours after delivery
Secondary	Maximum clot firmness (MCF)	INTEM, EXTEM, FIBTEM and APTEM / ROTEM	At the time when the blood loss exceeds 1500 ml and 45 min later
Secondary	Endogenous thrombin potential	CAT	At the time when the blood loss exceeds 1500 ml and 45 min later
Secondary	Fibrinogen level	Clauss method	At the time when the blood loss exceeds 1500 ml and 45 min later
Secondary	Platelet function	PFA-100	At the time when the blood loss exceeds 1500 ml and 45 min later
Secondary	Clotting time (CT)	INTEM, EXTEM, FIBTEM and APTEM / ROTEM	At the time when the blood loss exceeds 1500 ml and 45 min later
Secondary	Clot formation time (CFT)	INTEM, EXTEM, FIBTEM and APTEM / ROTEM	At the time when the blood loss exceeds 1500 ml and 45 min later