Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage: A Randomised Clinically Controlled Trial

NCT01359878 | Completed Phase 2 DMC

• 6 other identifiers: 2009-017736-4110021682612-42332007-58-0015-00911H-3-2010-0042009-315
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 4

Brief Summary

Severe maternal bleeding is a serious complication of birth and causes 125.000 deaths worldwide each year. The investigators aim to investigate if early treatment with fibrinogen concentrate versus saline can reduce the incidence of blood transfusion in women with postpartum haemorrhage. A low level of fibrinogen has been associated with increased blood loss and transfusion requirements in different clinical settings including obstetrical bleeding. Early up-front treatment with fibrinogen may reduce incidence of transfusion by securing optimal haemostatic capacity in women with postpartum haemorrhage. The investigators plan to enrol 245 patients on four hospitals in the Capital Region of Denmark during a two year period. As safety measure the investigators plan to use TEG®/Functional Fibrinogen/Rapid-TEG as haemostatic monitoring of all participants during the trial: Baseline test is taken at inclusion before administration of fibrinogen concentrate/placebo. Further tests are taken immediately after intervention, 4 hours and 24 hours after. Baseline test is blinded to the providers of treatment - the rest is clinically available.

Conditions

Postpartum Haemorrhage

Keywords

Postpartum haemorrhage; Postpartum bleeding; Postnatal bleeding; Fibrinogen concentrate; Transfusion; Haemostatis; Thrombelastography

Outcome Measures

Primary Outcomes (1)

• Incidense of transfusion with allogenic blood products

  During hospital stay or until 6 weeks postintervention

Secondary Outcomes (6)

• Severe Postpartum Haemorrhage (PPH)

  During hospital stay or until 6 weeks postintervention

• Estimated blood loss

  During hospital stay During hospital stay or until 6 weeks postintervention

• Total amount of blood transfused

  During hospital stay During hospital stay or until 6 weeks postintervention

• The development of re-bleeding

  Untill follow-up 6 weeks postintervention

• Hemoglobin level below 3,6 mmol/L

  During hospital stay or until 6 weeks postintervention

Study Arms (2)

Fibrinogen Concentrate

EXPERIMENTAL

Drug: Fibrinogen Concentrate

Placebo

PLACEBO COMPARATOR

Isotonic Saline

Drug: Isotonic Saline

Interventions

Fibrinogen Concentrate DRUG

2 gram intra venous

Also known as: Haemocomplettan, CSL Behring

Fibrinogen Concentrate

Isotonic Saline DRUG

Isotonic saline in equivalent volume - 100 ml

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent from participant.
• Women who develop PPH defined as bleeding from uterus and/or the birth canal within 24 hours postpartum.
• Age ≥ 18 years.
• If vaginal birth: indication of one of the following procedures at the operation theatre with anaesthetic assistance: a) Estimated blood loss ≥ 500 ml and indication of manual removal of placenta or b) Indication of manual exploration of the uterus due to continuous bleeding after the birth of placenta.
• If birth by Caesarean section: A perioperative blood loss ≥ 1000 ml.

You may not qualify if:

• Patients with known inherited deficiencies of coagulation.
• Patients in anti-thrombotic treatment prepartum due to increased risk of thrombosis.
• Patients with a pre-pregnancy weight \<45 kg.
• Patients who refuse to receive blood transfusion.

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead
• Rigshospitalet, Denmark: collaborator
• Copenhagen University Hospital, Hvidovre: collaborator
• Hillerod Hospital, Denmark: collaborator
• Blood Bank of the Danish capital region: collaborator
• Unit for monitoring of Good Clinical Practice Copenhagen University: collaborator
• Danish Council for Independent Research: collaborator
• Herlev Hospital: collaborator
• Laerdal Foundation: collaborator
• Aase and Ejnar Danielsens Foundation: collaborator
• The Foundation of 17.12.1981: collaborator
• Fonden til Lægevidenskabens Fremme: collaborator
• Hans og Nora Buchards Fond: collaborator
• Haemonetics Corporation: collaborator

Study Sites (4)

Juliane Marie Centre, Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location

University Hospital of Herlev

Herlev, Capital Region, 2730, Denmark

Location

University Hospital of Hilleroed

Hilleroed, Capital Region, 3400, Denmark

Location

University Hospital of Hvidovre

Hvidovre, Capital Region, 2650, Denmark

Location

Related Publications (2)

• Wikkelso AJ, Edwards HM, Afshari A, Stensballe J, Langhoff-Roos J, Albrechtsen C, Ekelund K, Hanke G, Secher EL, Sharif HF, Pedersen LM, Troelstrup A, Lauenborg J, Mitchell AU, Fuhrmann L, Svare J, Madsen MG, Bodker B, Moller AM; FIB-PPH trial group. Pre-emptive treatment with fibrinogen concentrate for postpartum haemorrhage: randomized controlled trial. Br J Anaesth. 2015 Apr;114(4):623-33. doi: 10.1093/bja/aeu444. Epub 2015 Jan 13.

  PMID: 25586727 DERIVED

• Wikkelsoe AJ, Afshari A, Stensballe J, Langhoff-Roos J, Albrechtsen C, Ekelund K, Hanke G, Sharif HF, Mitchell AU, Svare J, Troelstrup A, Pedersen LM, Lauenborg J, Madsen MG, Bodker B, Moller AM. The FIB-PPH trial: fibrinogen concentrate as initial treatment for postpartum haemorrhage: study protocol for a randomised controlled trial. Trials. 2012 Jul 17;13:110. doi: 10.1186/1745-6215-13-110.

  PMID: 22805300 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Fibrinogen; Sodium Chloride

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

Intervention Hierarchy (Ancestors)

Acute-Phase Proteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Blood Coagulation Factors; Protein Precursors; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Anne J. Wikkelsoe, MD

  Department of Anaesthesiology, University Hospital of Herlev, Denmark

  PRINCIPAL INVESTIGATOR

• Ann M. Møller, MD, DmSc

  Department of Anaesthesiology, University Hospital of Herlev, Denmark

  STUDY CHAIR

• Jakob Stensballe, MD, PhD

  Blood Bank of Danish Capital Region, Rigshospitalet

  STUDY CHAIR

• Jens Langhoff-Roos, MD, DmSc

  Department of Obstetrics, Juliane Marie Centre, Rigshospitalet

  STUDY CHAIR

• Arash Afshari, MD

  Department of Anaesthesiology, Juliane Marie Centre, Rigshospitalet, Denmark

  STUDY CHAIR

• Hellen McKinnon Edwards, M.D.

  Dep. of Anaesthesiology, Herlev

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: May 25, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 20, 2013

Record last verified: 2013-09

Locations

DK (4)