PCC and Fibrinogen Compared With FFP in PPH

NCT01910675 | Withdrawn Phase 4

• 2 other identifiers: EudraCT-2012-003128U1030N7560
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Haemorrhage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Maximum clot firmness (MCF)

  At the time when the blood loss exceeds 1500 ml and 45 min later

• Endogenous thrombin potential

  At the time when the blood loss exceeds 1500 ml and 45 min later

• Fibrinogen level

  At the time when the blood loss exceeds 1500 ml and 45 min later

• Platelet function

  At the time when the blood loss exceeds 1500 ml and 45 min later

• Clotting time (CT)

  At the time when the blood loss exceeds 1500 ml and 45 min later

Study Arms (2)

PCC group

EXPERIMENTAL

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

FFP group

ACTIVE COMPARATOR

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

Interventions

PCC DRUG

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

Also known as: Octaplex, Riastab

PCC group

FFP DRUG

4 units Octaplas. Additional fibrinogen if needed.

Also known as: Octaplas

FFP group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Maternity Hospital, Helsinki University Central Hospital

Helsinki, Uusimaa, FI-00610, Finland

Location

Related Publications (1)

• 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.

  PMID: 21069897 BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

prothrombin complex concentrates

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jouni V. Ahonen, Ph.D., M.D.

  Maternity Hospital, Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant anaesthesiologist, M.D., Ph.D.

Study Record Dates

• First Submitted: July 13, 2013
• First Posted: July 30, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 10, 2018

Record last verified: 2018-10

Locations

FI (1)