Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: REPLACE (Randomized Evaluation of Fibrinogen Versus Placebo in Complex Cardiovascular Surgery): a Prospective, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study for the Use of Fibrinogen Concentrate (Human) (FCH) in Complex Cardiovascular Surgery
Brief Summary: The purpose of this study is to demonstrate that Fibrinogen Concentrate (Human)(FCH) can reduce the amount of donor blood products needed during complex cardiovascular surgery, and that it is safe and well tolerated. Subjects in this study will get either a FCH or placebo infusion during surgery. This will be in addition to the standard treatment, which is donor blood or blood products. Placebo does not contain any effective medicine.

The study is randomised. This means that the likelihood that subjects will get FCH or placebo is 50%. To make the comparison between FCH and placebo as fair as possible, the study is "double blind". This means that neither the subjects nor the study doctor will know if FCH or placebo is administered. If necessary, the study doctor can find out which treatment the subjects are receiving.


Options:
A: Arm Label: IG1202-A (Vascular); Type: EXPERIMENTAL; Interventions: Biological: Human thrombin, Biological: Bovine thrombin | Arm Label: IG1202-B (Hepatic); Type: EXPERIMENTAL; Interventions: Biological: Human thrombin, Biological: Bovine thrombin | Arm Label: IG1202-C (Soft Tissue); Type: EXPERIMENTAL; Interventions: Biological: Human thrombin, Biological: Bovine thrombin | Arm Label: IG1202-D (Spinal); Type: EXPERIMENTAL; Interventions: Biological: Human thrombin, Biological: Bovine thrombin | Intervention Type: BIOLOGICAL; Name: Human thrombin; Assigned to Arm(s): IG1202-A (Vascular), IG1202-B (Hepatic), IG1202-C (Soft Tissue), IG1202-D (Spinal) | Intervention Type: BIOLOGICAL; Name: Bovine thrombin; Assigned to Arm(s): IG1202-A (Vascular), IG1202-B (Hepatic), IG1202-C (Soft Tissue), IG1202-D (Spinal)
B: 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
C: Arm Label: Tranexamic Acid; Type: EXPERIMENTAL; Interventions: Drug: tranexamic acid diluted in 100 ml of saline solution (loading dose), Drug: tranexamic acid undiluted (continous infusion) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: tranexamic acid diluted in 100 ml of saline solution (loading dose); Assigned to Arm(s): Tranexamic Acid | Intervention Type: DRUG; Name: tranexamic acid undiluted (continous infusion); Assigned to Arm(s): Tranexamic Acid | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Fibrinogen Concentrate (Human); Type: EXPERIMENTAL; Interventions: Biological: Fibrinogen Concentrate (Human) (FCH) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Intervention Type: BIOLOGICAL; Name: Fibrinogen Concentrate (Human) (FCH); Assigned to Arm(s): Fibrinogen Concentrate (Human) | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo

Answer: D