PCC and Fibrinogen Compared With FFP in PPH

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.

Study Overview

• Status: Withdrawn
• Conditions: Postpartum Haemorrhage
• Intervention / Treatment: Drug: PCC; Drug: FFP

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).

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, FI-00610
      • Maternity Hospital, Helsinki University Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: PCC; 15 IU/kg Octaplex and 2 g Riastab. Additional fibrinogen if needed.; Other Names: Octaplex, Riastab
Active Comparator: 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).	Drug: FFP; 4 units Octaplas. Additional fibrinogen if needed.; Other Names: Octaplas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum clot firmness (MCF)	INTEM, EXTEM, FIBTEM and APTEM / ROTEM	At the time when the blood loss exceeds 1500 ml and 45 min later
Endogenous thrombin potential	CAT	At the time when the blood loss exceeds 1500 ml and 45 min later
Fibrinogen level	Clauss method	At the time when the blood loss exceeds 1500 ml and 45 min later
Platelet function	PFA-100	At the time when the blood loss exceeds 1500 ml and 45 min later
Clotting time (CT)	INTEM, EXTEM, FIBTEM and APTEM / ROTEM	At the time when the blood loss exceeds 1500 ml and 45 min later
Clot formation time (CFT)	INTEM, EXTEM, FIBTEM and APTEM / ROTEM	At the time when the blood loss exceeds 1500 ml and 45 min later

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Principal Investigator: Jouni V. Ahonen, Ph.D., M.D., Maternity Hospital, Helsinki University Central Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: July 13, 2013
• First Submitted That Met QC Criteria: July 29, 2013
• First Posted (Estimate): July 30, 2013

Study Record Updates

• Last Update Posted (Actual): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 8, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: EudraCT-2012-003128; U1030N7560 (Other Identifier: HUCH)