Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage - A Randomised Clinically Controlled Trial
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.


Options:
A: Arm Label: Haemocomplettan® P; Type: ACTIVE_COMPARATOR; Interventions: Biological: Haemocomplettan® P | Arm Label: Saline solution; Type: PLACEBO_COMPARATOR; Interventions: Biological: Saline solution | Intervention Type: BIOLOGICAL; Name: Haemocomplettan® P; Assigned to Arm(s): Haemocomplettan® P | Intervention Type: BIOLOGICAL; Name: Saline solution; Assigned to Arm(s): Saline solution
B: Arm Label: Fibrinogen Concentrate; Type: EXPERIMENTAL; Interventions: Drug: Fibrinogen Concentrate | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Isotonic Saline | Intervention Type: DRUG; Name: Fibrinogen Concentrate; Assigned to Arm(s): Fibrinogen Concentrate | Intervention Type: DRUG; Name: Isotonic Saline; Assigned to Arm(s): Placebo
C: Arm Label: Liberal (10 g/dL) Transfusion Strategy; Type: EXPERIMENTAL; Interventions: Biological: Liberal (10 g/dL) Transfusion Strategy | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Biological: Restrictive (Symptomatic) Transfusion Strategy | Intervention Type: BIOLOGICAL; Name: Liberal (10 g/dL) Transfusion Strategy; Assigned to Arm(s): Liberal (10 g/dL) Transfusion Strategy | Intervention Type: BIOLOGICAL; Name: Restrictive (Symptomatic) Transfusion Strategy; Assigned to Arm(s): 2
D: Arm Label: Coagulation factor concentrates; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fibrinogen concentrate, Prothrombin complex concentrate and FXIII concentrate | Arm Label: Fresh Frozen Plasma; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fresh Frozen Plasma blood type 0, A, B and AB | Intervention Type: DRUG; Name: Fibrinogen concentrate, Prothrombin complex concentrate and FXIII concentrate; Assigned to Arm(s): Coagulation factor concentrates | Intervention Type: DRUG; Name: Fresh Frozen Plasma blood type 0, A, B and AB; Assigned to Arm(s): Fresh Frozen Plasma

Answer: B