Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Fibrinogen Concentrate vs Cryoprecipitate in Traumatic Haemorrhage: A Pilot Randomised Controlled Trial
Brief Summary: * Haemorrhage in severe trauma is a significant cause of mortality and is potentially the most preventable cause of death in trauma patients
* Trauma Induced Coagulopathy (TIC) is a complex coagulopathy associated with severe trauma
* Hypo/dysfibrinogenaemia plays an important role in TIC
* Early replacement of fibrinogen may improve outcomes
* Fibrinogen replacement is potentially inadequate in standard fixed ratio Major Haemorrhage Protocols (MHP) utilising Plasma and/or Cryoprecipitate
* The majority of centres utilise cryoprecipitate for additional fibrinogen supplementation as part of a MHP
* Cryoprecipitate administration is often delayed (between 60 - 120 minutes) in a fixed ratio MHP
* It is clear early intervention in severe traumatic haemorrhage is associated with improved outcomes - CRASH 2 and PROPPR studies
* Increasing interest in the use of Fibrinogen Concentrate (FC) in severe bleeding but not supported by high level evidence
* Benefits of FC - viral inactivation, known dose, easily reconstituted, can be administered quickly in high dose and stored at room temperature in the trauma resuscitation bay
* No previous studies comparing FC and Cryoprecipitate in bleeding trauma patients
* Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment algorithm
* It will be a pilot, multi-centre randomised controlled trial comparing FC to Cryoprecipitate (current standard practise in fibrinogen supplementation)
* Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate
* It is imperative that robust and clinically relevant trials are performed to investigate fibrinogen supplementation in trauma before widespread adoption makes performing such studies unfeasible


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: 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
C: 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
D: Arm Label: Fibrinogen Concentrate; Type: EXPERIMENTAL; Interventions: Drug: Fibrinogen Concentrate | Arm Label: Cryoprecipitate; Type: ACTIVE_COMPARATOR; Interventions: Other: Cryoprecipitate | Intervention Type: DRUG; Name: Fibrinogen Concentrate; Assigned to Arm(s): Fibrinogen Concentrate | Intervention Type: OTHER; Name: Cryoprecipitate; Assigned to Arm(s): Cryoprecipitate

Answer: D