The Efficacy and Costeffectiveness of Fibrinogen Concentrate Compared

The Efficacy and Cost-effectiveness of Fibrinogen Concentrate Compared With Cryoprecipitate in Major Bleeding Patients NAC Meeting Edmonton April 2016

The Efficacy and Cost-effectiveness of Fibrinogen Concentrate Compared With Cryoprecipitate in Major Bleeding Patients (1) Ø Patients for the study would be identified by having a cryoprecipitate order placed for infusion. The TM physician would then contact the attending physician and ask if they would be willing to switch to fibrinogen concentrate instead. Fibrinogen concentrate would then be administered in the following doses: Ø Cardiovascular patients would receive a 2. 0 -4. 0 gr of fibrinogen following the current recommendation. Ø Non-cardiac patients would receive a low dose FC (1. 02. 0 gr) dose.

The Efficacy and Cost-effectiveness of Fibrinogen Concentrate Compared With Cryoprecipitate in Major Bleeding Patients (2) Ø A total of 120 patients will be selected for the study (60 fibrinogen and 60 cryo). Cryo recipients may be selected from patient who had been already transfused and relevant timely lab data is available for those patients. Ø A chart review would be conducted of approximately 60 patients that received or will receive Cryoprecipitate in 2014/15/16 and of approximately 60 patients that will received fibrinogen concentrate in 2015/16. Ø The data would be analyzed in 2 separate groups: cardiovascular patients and non-cardiovascular patients based on the different dosing schedules. Ø Non-cardiovascular patients may be analyzed in two subgroups of Massively bleeding/non-Massively bleeding (<6 RCs)

The Efficacy and Cost-effectiveness of Fibrinogen Concentrate (Dosing Schedule) • • FIBRINOGEN Concentrate (Ria. STAP) Each vial of Ria. STAP contains 1. 0 gram of Fibrinogen concentrate and increases the fibrinogen levels by 0. 5 g/L which is equal to increments achieved by a pool of 10 cryoprecipitate. Dosage suggestions: 1 vials of Ria. STAP (1 grams) when the fibrinogen level is 0. 5 -1. 0 g/L (non-Massively bleeding; mild bleeding, mucosal bleeding etc. . ). 2 vials of Ria. STAP (2 grams) when the fibrinogen level is <1. 0 g/L (Massively Bleeding pts). 1 vial of Ria. STAP when the patient’s Fibrinogen level is between 1. 0 -1. 49 g/L and there is a significant drop in Fibrinogen within the last 6 hours. For STAT cases with coagulopathic bleeding and fibrinogen levels are not available, approve the first vial (1 gram) but the second vial will not be released until the fibrinogen levels are tested (these levels should be collected to be tested before the administration of the first dose of Ria. Stap). Cardiac surgery – up to 4 g per dose is acceptable.

Fibrinogen Result Greater 1. 0 – 1. 49 gr/L and a 0. 5 - 1. 0 gr/L than significant drop in 1. 5 gr/L Fibrinogen levels in last 6 hours Less than 0. 5 gr/L Ria. STAP® Dosing No vials 1 gram (1 vial) 2 grams (2 vials) 1 gram (1 vial) Non-MB 2 gram (1 vial) Massive Bleeding First vial may be released if Repeat Fibrinogen level is not available. Release of 2 nd vial requires Fibrinogen level and TM physician approval. (2 grams is a total maximum dose). Release of first 2 vials without fibrinogen level is approved for Cardiac or Vascular surgery patients. Additional vials require Fibrinogen level and TM physician approval.