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PCC and Fibrinogen Compared With FFP in PPH

Sponsor
Helsinki University Central Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01910675
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
63
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Use of Prothrombin Complex Concentrate and Fibrinogen Compared With Fresh Frozen Plasma (and Fibrinogen if Needed) in the Treatment of Postpartum Haemorrhage
Study Start Date :
Jul 1, 2013
Anticipated Primary Completion Date :
Oct 1, 2018
Anticipated Study Completion Date :
Oct 1, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Blood loss [Within the first 6 and 24 hours after delivery]

      The suctioned blood is recorded and sponges, wraps, swabs, etc. are carefully weighed. The amount of blood loss will be compared between the groups.

    Secondary Outcome Measures

    1. Maximum clot firmness (MCF) [At the time when the blood loss exceeds 1500 ml and 45 min later]

      INTEM, EXTEM, FIBTEM and APTEM / ROTEM

    2. Endogenous thrombin potential [At the time when the blood loss exceeds 1500 ml and 45 min later]

      CAT

    3. Fibrinogen level [At the time when the blood loss exceeds 1500 ml and 45 min later]

      Clauss method

    4. Platelet function [At the time when the blood loss exceeds 1500 ml and 45 min later]

      PFA-100

    5. Clotting time (CT) [At the time when the blood loss exceeds 1500 ml and 45 min later]

      INTEM, EXTEM, FIBTEM and APTEM / ROTEM

    6. Clot formation time (CFT) [At the time when the blood loss exceeds 1500 ml and 45 min later]

      INTEM, EXTEM, FIBTEM and APTEM / ROTEM

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maternity Hospital, Helsinki University Central Hospital Helsinki Uusimaa Finland FI-00610

    Sponsors and Collaborators

    • Helsinki University Central Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jouni Ahonen, Consultant anaesthesiologist, M.D., Ph.D., Helsinki University Central Hospital
    ClinicalTrials.gov Identifier:
    NCT01910675
    Other Study ID Numbers:
    • EudraCT-2012-003128
    • U1030N7560
    First Posted:
    Jul 30, 2013
    Last Update Posted:
    Oct 10, 2018
    Last Verified:
    Oct 1, 2018
    Additional relevant MeSH terms:
    Postpartum Hemorrhage
    Hemorrhage

    Study Results

    No Results Posted as of Oct 10, 2018