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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Experimental design Design: We plan to conduct a randomised double-blinded clinically controlled trial: The participants are assigned to either 1) placebo (100 ml of isotonic saline) i.v. or 2) the intervention drug: 2 g of fibrinogen concentrate (Haemocomplettan, CSL Behring) i.v. We intend to use a fixed dose for all patients randomized to the intervention group without prior measurement of the fibrinogen level. This strategy is primarily based on the clinical urgency since the treatment is required to be administered as early as possible.

Materials and duration of study Patients will be included during a two year period at the four largest hospitals in the Capital Region: Rigshospitalet, Hvidovre, Hillerød and Herlev if they fulfil the following eligibility criteria Plan of trial execution In order to secure the ethical aspect "Time for reflection" we will provide all pregnant women who appear in the centres during the trial period with written information on the trial during their midwife evaluation. Only 1,75% of these women are estimated to meet the inclusion criteria postpartum.

Intensive haemostatic monitoring Haemostatic blood samples including thrombelastography (TEG®), functional fibrinogen-assay for TEG®, Rapid-TEG, fibrinogen-level, d-Dimer, INR (international normalized ratio), platelet count and Antithrombin III will be drawn 15 minutes after the intervention is given, 4 hours and 24 hours later. The samples taken after the intervention are fully available for evaluation by the clinicians responsible for the patient. The patient will be observed with blood pressure, pulseoximetry, ECG and possible side effects or re-bleeding will be evaluated.

Follow up The patients will remain hospitalized for a minimum of 24 hours. We will contact all participants by phone six weeks after the intervention. Upon discharge from the hospital, all included patients receive information-material addressing possible late side effects and a contact number.

Conditions

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Postpartum Haemorrhage

Keywords

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Postpartum haemorrhage Postpartum bleeding Postnatal bleeding Fibrinogen concentrate Transfusion Haemostatis Thrombelastography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fibrinogen Concentrate

Group Type EXPERIMENTAL

Fibrinogen Concentrate

Intervention Type DRUG

2 gram intra venous

Placebo

Isotonic Saline

Group Type PLACEBO_COMPARATOR

Isotonic Saline

Intervention Type DRUG

Isotonic saline in equivalent volume - 100 ml

Interventions

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Fibrinogen Concentrate

2 gram intra venous

Intervention Type DRUG

Isotonic Saline

Isotonic saline in equivalent volume - 100 ml

Intervention Type DRUG

Other Intervention Names

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Haemocomplettan, CSL Behring

Eligibility Criteria

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Inclusion Criteria

1. Informed consent from participant.
2. Women who develop PPH defined as bleeding from uterus and/or the birth canal within 24 hours postpartum.
3. Age ≥ 18 years.
4. 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.
5. If birth by Caesarean section: A perioperative blood loss ≥ 1000 ml.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Anne Juul Wikkelsø

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne J. Wikkelsoe, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology, University Hospital of Herlev, Denmark

Ann M. Møller, MD, DmSc

Role: STUDY_CHAIR

Department of Anaesthesiology, University Hospital of Herlev, Denmark

Jakob Stensballe, MD, PhD

Role: STUDY_CHAIR

Blood Bank of Danish Capital Region, Rigshospitalet

Jens Langhoff-Roos, MD, DmSc

Role: STUDY_CHAIR

Department of Obstetrics, Juliane Marie Centre, Rigshospitalet

Arash Afshari, MD

Role: STUDY_CHAIR

Department of Anaesthesiology, Juliane Marie Centre, Rigshospitalet, Denmark

Hellen McKinnon Edwards, M.D.

Role: STUDY_CHAIR

Dep. of Anaesthesiology, Herlev

Locations

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Juliane Marie Centre, Rigshospitalet

Copenhagen, Capital Region, Denmark

Site Status

University Hospital of Herlev

Herlev, Capital Region, Denmark

Site Status

University Hospital of Hilleroed

Hilleroed, Capital Region, Denmark

Site Status

University Hospital of Hvidovre

Hvidovre, Capital Region, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED

PMID: 25586727 (View on PubMed)

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.

Reference Type DERIVED

PMID: 22805300 (View on PubMed)