Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: RETIC Trial: Reversal of Trauma Induced Coagulopathy Using Coagulation Factor Concentrates or Fresh Frozen Plasma
Brief Summary: Severe traumatized patients (ISS \> 15) admitted to emergency department (ED) University Hospital Innsbruck with obvious bleeding and/or who are at risk for significant hemorrhage will be screened by rotational thrombelastometry (ROTEM) assays during ED treatment and subsequent surgical/radiological interventions for having coagulopathy (T0). If a patient meets the inclusion criteria (T1) and is recruited for the study, a first study related blood sample (40mL) will be drawn, and data collected. Subsequently, 100 patients will be randomized to receive Fibrinogen concentrate and/or Prothrombin complex concentrate and/or FXIII concentrate for reversal of coagulopathy, while the other 100 patients will receive fresh frozen plasma (FFP),respectively.

Treatment failure will be registered if bleeding persists and ROTEM parameters do not improve after two times dosages of study drug. In these cases haemostatic rescue therapy will be administered. CFC (fibrinogen concentrate and/or PCC, and/or FXIII concentrate) will be administered to patients randomized to receive FFP and FFP will be administered to patients of the CFC group.

In cases unresponsive to comprehensive treatment or normal ROTEM combined with diffuse bleeding, other haemostatic medications can be administered (e.g rFVIIa, DDAVP, VWF/FVIII concentrate) as judged by the anesthetist in charge. The need and type of any rescue therapy will be documented and a ROTEM will be performed thereafter.

At admission to ICU (T0 ICU), 24h (T24 ICU) and 48h(T48 ICU) thereafter further study related blood samples are drawn (40mL each).

The indications for transfusion of red blood cells or platelets, administration of antifibrinolytics, treatment of acidosis, hypothermia, hypocalcemia and volume replacement are similar for both groups and treatment is performed according to clinical routine.

Besides coagulation management during ED treatment until 24h on ICU, patient's care is not influenced by the study and follows clinical routine.


Options:
A: 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
B: 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
C: Arm Label: Saline solution; Type: PLACEBO_COMPARATOR; Interventions: Drug: Saline solution | Arm Label: Fibrinogen; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fibrinogen | Arm Label: Prothrombin complex; Type: ACTIVE_COMPARATOR; Interventions: Drug: Prothrombin complex | Intervention Type: DRUG; Name: Fibrinogen; Assigned to Arm(s): Fibrinogen | Intervention Type: DRUG; Name: Saline solution; Assigned to Arm(s): Saline solution | Intervention Type: DRUG; Name: Prothrombin complex; Assigned to Arm(s): Prothrombin complex
D: Arm Label: Tranexamic acid; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tranexamic acid | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo [Saline] | Intervention Type: DRUG; Name: Tranexamic acid; Assigned to Arm(s): Tranexamic acid | Intervention Type: DRUG; Name: Placebo [Saline]; Assigned to Arm(s): placebo

Answer: A