Postpartum Haemorrhage Clinical Trial
— FIB-PPHOfficial title:
Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage - A Randomised Clinically Controlled Trial
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.
Status | Completed |
Enrollment | 249 |
Est. completion date | July 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Denmark | Juliane Marie Centre, Rigshospitalet | Copenhagen | Capital Region |
Denmark | University Hospital of Herlev | Herlev | Capital Region |
Denmark | University Hospital of Hilleroed | Hilleroed | Capital Region |
Denmark | University Hospital of Hvidovre | Hvidovre | Capital Region |
Lead Sponsor | Collaborator |
---|---|
Copenhagen University Hospital at Herlev | Aase and Ejnar Danielsens Foundation, Blood Bank of the Danish capital region, Copenhagen University Hospital, Hvidovre, Danish Council for Independent Research, Fonden til Lægevidenskabens Fremme, Haemonetics Corporation, Hans og Nora Buchards Fond, Herlev Hospital, Hillerod Hospital, Denmark, Laerdal Acute Foundation, Rigshospitalet, Denmark, The fund of 17-12-1981, Unit for monitoring of Good Clinical Practice Copenhagen University |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidense of transfusion with allogenic blood products | During hospital stay or until 6 weeks postintervention | No | |
Secondary | Severe Postpartum Haemorrhage (PPH) | Development of "Severe PPH" defined as: "Decrease of haemoglobin (Hb) of > 2,5 mmol/L, transfusion of at least 4 Red Blood Cell (RBC) units, haemostatic intervention (angiographic embolization, surgical arterial ligation or hysterectomy) or death. | During hospital stay or until 6 weeks postintervention | No |
Secondary | Estimated blood loss | During hospital stay During hospital stay or until 6 weeks postintervention | No | |
Secondary | Total amount of blood transfused | During hospital stay During hospital stay or until 6 weeks postintervention | No | |
Secondary | The development of re-bleeding | Defined as bleeding reoccuring after primary haemostasis, and requiring surgical procedures or intervention | Untill follow-up 6 weeks postintervention | Yes |
Secondary | Hemoglobin level below 3,6 mmol/L | During hospital stay or until 6 weeks postintervention | No | |
Secondary | Side-effects including thromboembolic complications | Safety measures/ Potential known side effects such as: Fever, headache, nausea, vomiting, allergic reactions, anaphylaxis and thrombo-embolic complications (deep venous thrombosis, acute myocardial infarct and lung embolus. All suspected unexpected serious adverse reactions will also be reported in accordance with the Good Clinical Practice (GCP) and the Danish Medicines Agency guidelines. | Untill 6 weeks postintervention | Yes |
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