Plasma Products: Thawed, Liquid, Dried and Beyond

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1 Plasma Products: Thawed, Liquid, Dried and Beyond John B. Holcomb, MD, FACS Professor of Surgery Chief, Division of Acute Care Surgery Director, Center for Translational Injury Research University of Texas Health Science Center Houston, TX 1

2 Disclosures Founder and on the board of Decisio Health The PROPPR Study was Funded by NIH DoD funded for prehospital multicenter transfusion study 2

3 Bottom Line Up Front Hemorrhage is the leading potentially preventable cause of trauma death Crystalloid resuscitation increase blood loss, transfusion requirements and death Balanced blood product resuscitation decreases blood loss, transfusion requirements and improves survival Plasma as the primary resuscitation fluid Must have thawed/liquid plasma in the ED or prehospital to really do this well Time is critical 3

J Trauma, 2007. Rapid progress in trauma care occurs during a war.

4 J Trauma, Rapid progress in trauma care occurs during a war. Damage control resuscitation addresses diagnosis and treatment of the entire lethal triad immediately upon admission. 4

5 DCR components Stop bleeding Hypotensive resuscitation Minimize crystalloid Use plasma to resuscitate patients Increased platelet use Reverse hypothermia and acidosis Hemostatic adjuncts 5

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7 J Trauma 2011 In the next evolution of transfusion practice, it is exciting to consider the real logistical and clinical benefits of exclusively using dried products such as plasma, platelets, fibrinogen, and RBCs to resuscitate bleeding patients, available at the point of care. Dried Plasma and fibrinogen will replace all time sensitive use of FFP and Cryo Essentially all transfusions for bleeding 7

8 JSOM 2014 The resuscitation fluids of choice for casualties in hemorrhagic shock are (in priority order): whole blood, plasma, RBCs and platelets in 1:1:1 ratio; plasma and RBCs in 1:1 ratio; plasma or RBCs alone; Hextend; crystalloid (lactated Ringer s or Plasma-Lyte A). 8

9 How do you make early blood products happen? Work with the Blood bank and Donor Center O- RBCs in the ED and prehospital AB or A plasma in the ED and prehospital Thawed or Liquid plasma Platelets in the ED and prehospital Prehospital and in the ED 9

10 Transfusion FFP 2. Thawed 3. Liquid 4. Dried 10

11 11

12 Plasma Options and Time FFP (requires thawing) 4 hours Time and breakage Thawed plasma 5 days Degradation Liquid plasma 25 days degradation AB or low titer A 12

13 Copenhagen and Houston 13

14 Does it Translate? Impact of Contemporary Military Medicine on Civilian Trauma Care AH Haider MD, et al. Surgery 2015 Survey of 650 TMDs. For DCR, 86% of responding centers reported use of a 1:1:1 PRBC:FFP:PLT ratio. This national survey of TMDs suggests that military data supporting DCR has significantly altered civilian practice. 14

15 Changing Use of Plasma in the US The combined total of WBD and apheresis plasma 3,882,000 units transfused in % less than ,484,000 units However in 2011 there were 1,181,000 units of thawed plasma transfused 30.4% of all plasma transfused. Of all plasma transfused 142,000 were Group AB. 15

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17 Freeze Dried Plasma Project Update, Feb 18,

18 Prehospital and Hospital No distinction Should be a seamless continuum What works in the hospital should be used prehospital Not slow down transport Basic premise of EMS 5000 Hospitals 1852 trauma centers 50,000 ambulances 18

19 Translation Large centers with: lots of trauma Lots of big elective surgery Lots of cancer For the other 4000 hospitals and their patients out of luck 19

prevents injurious neutrophilendothelial interaction.

20 Anes & Analg, 2011 The glycocalyx is a ubiquitous barrier that protects the underlying endothelium and prevents injurious neutrophilendothelial interaction. A C A = baseline B= shock C = LR resus C = Plasma resus B D 20

21 J Trauma 2011 The HP and clot forming ability of TP significantly declined with storage. FFP-0 TP may have a greater ability to restore hemostasis and correct coagulopathy compared with FFP-5. The clinical consequences for transfused patients deserve further exploration. 21

22 J Trauma 2012 Thrombin 22

23 J Trauma, 2014 LQP corrected TNF-α induced EC permeability and preserved hemostatic potential after 28 days of storage, similar to TP stored for 5 days. 23

24 Thawed and Liquid Plasma 5 day vs 23 day storage Spreading across trauma centers 80% use the 1:1:1 approach Funded DoD trials Many helicopter services Ground EMS systems Practice changing despite inadequate products 24

25 Trans 2013 Describes their regulatory and substantial clinical experience with dried plasma 1945 to current Pathogen reduced 25

26 Trans

27 WBC Adhesion 27

28 Trans

29 Shock

30 Back to the Future Lyophilized Plasma Resuscitation 30

31 German Dried Plasma in the IDF 31

32 Shock,

33 French Dried Plasma Product carried by some US Special Operations Forces. Approved by FDA and WH 33

34 Different Dried Plasmas Several US companies working on dried plasma Other ProCoagulant Productss

35 Very Small, lightweight as a dried product

36 Plasma Studies Excellent baseline standard of care from the many recent studies PROMMTT and PROPPR and PROHS New more logistically favorable products need rapid preclinical evaluation and then appropriate human studies Must be dried, storage for 2 years at ambient temp, rapid mixing and universal donor 36

37 Permeability? Reversal of endothelial damage associated with TBI and Shock Decrease edema and MOF Liquid Plasma does this very well One of the dried plasma products Do the PCC products? 6 proteins? Do the fibrinogen products? Cost of products? 37

38 What do we do - today Identify patients who need resuscitation Prehospital and hospital Use blood products, not crystalloid or artificial colloids Transfuse in a balanced fashion, starting with the first units Platelets and plasma early Documented improved outcomes 38

39 Lyophilized Fibrinogen The Future Dried / Lyophilized Components Used for trauma patients in Austria Approved in US Frozen, FD platelets or Lyophilized Platelets human studies and animal trials (LP) European countries in Afghanistan Dried plasma animal studies Human trials Approved in many EU countries, used in Afghanistan and Israel RBCs Stem cell derived-darpa lyophilized RBC s? Various individual coagulation proteins 39

J Trauma 2011 In the next evolution of transfusion practice, it is exciting to consider the real logistical and clinical benefits of exclusively using dried products such as plasma, platelets,

40 J Trauma 2011 In the next evolution of transfusion practice, it is exciting to consider the real logistical and clinical benefits of exclusively using dried products such as plasma, platelets, fibrinogen, and RBCs to resuscitate bleeding patients, available at the point of care. Dried Plasma and fibrinogen will replace all time sensitive use of FFP and Cryo Essentially all transfusions for bleeding 40

41 Thank You The entire physician, resident, nursing, administrative, and technical team at MHH and UT Dr Beth Hartwell Dr Yu Bai Ms Rhonda Hobbs 41

Plumbing 101:! TXA and EMS! Jay H. Reich, MD FACEP! EMS Medical Director! City of Kansas City, Missouri/Kansas City Fire Department!

Plumbing 101:! TXA and EMS! Jay H. Reich, MD FACEP! EMS Medical Director! City of Kansas City, Missouri/Kansas City Fire Department! EMS Section Chief! Department of Emergency Medicine! University of Missouri-Kansas