drugset / Trial / NCT02736812
Pre-hospital Administration of Lyophilized Plasma for Post-traumatic Coagulopathy Treatment (PREHO-PLYO)
Phase 3
Completed
140 enrolled
French Defence Health Service
Bataillon des marins pompiers de Marseille, France · collabCH Annecy Genevois · collabCentre de transfusion sanguine des Armées, Clamart, France · collabFire Brigade Of Paris Emergency Medicine Dept · collabHenri Mondor University Hospital · collabHôpital Edouard Herriot · collabInstitut de Recherche Biomedicale des Armees · collabLyon-South Hospital, France · collabMarseille North Hospital, France · collabMilitary Hospital Begin, Saint-Mandé, France · collabMilitary Hospital Laveran,Marseille, France · collabMilitary Hospital Percy , Clamart, France · collabSamu of Annecy, France · collabSamu of Beaujon, Clichy-La-Garenne, France · collabSamu of Brest, Brest , France · collabSamu of Henri Mondor, Créteil, France · collabSamu of Lariboisière, Paris, France · collabSamu of Lyon, France · collabSamu of Marseille, France · collabSamu of Necker, Paris, France · collabSamu of Pau , Pau , France · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
In severe bleeding due to trauma, a decrease in coagulation factors maintains and promotes bleeding. The plasma allows, through its contribution of coagulation factors, early prevention or correction of this post-trauma induced coagulopathy. This study aims to measure the effectiveness of pre-hospital FLYP administration in case of traumatic hemorrhagic shock, in the occurrence or the treatment of a post traumatic induced coagulopathy. Study Design This is a randomized controlled multicenter open label study in two parallel groups. Eligibility criteria : adult, victim of a hemorrhagic shock of traumatic origin with \[systolic blood pressure \<70 mmHg\] or Shock Index \>1.1 The patients will receive either FLYP either the usual treatment as given in the recommendations for best practice. The primary endpoint is the International Normalized Ratio (INR) at hospital admission. The study must confirm the link between causality of early administration of plasma in improving post-traumatic coagulopathy. The study must show safe usage in out-of-hospital situations and the ability of medical staff to meet the requirements of the health authorities in terms of product use as well as in terms of traceability of the victims and the treatment they received.
Timeline
- Start
- 2016-04-01
- Primary completion
- 2019-10-31
- Completion
- 2019-11-30
Outcome
Missed primary endpoint
paper prehospital transfusion of lyophilized plasma was not associated with significant differences in INR values vs standard care with normal saline infusion. PMID 35881397 ↗
Publications
- Background Boutonnet M, Pasquier P, Salvadori A, Auroy Y, Tourtier JP. Advocacy to extend the use of continuous noninvasive hemoglobin measurement. Crit Care Med. 2011 Dec;39(12):2783-4; author reply 2784-5. doi: 10.1097/CCM.0b013e31822b3a22. No abstract available.
- Background Pasquier P, Boutonnet M, Giraud N, Salvadori A, Tourtier JP. Hypotension redefined, shock index and massive transfusion. J Trauma. 2011 Sep;71(3):784-5. doi: 10.1097/TA.0b013e318228b83d. No abstract available.
- Background Brohi K, Singh J, Heron M, Coats T. Acute traumatic coagulopathy. J Trauma. 2003 Jun;54(6):1127-30. doi: 10.1097/01.TA.0000069184.82147.06.
- Background Martinaud C, Tourtier JP, Pasquier P, Ausset S, Sailliol A. The French freeze-dried plasma. J Trauma. 2011 Oct;71(4):1091-2. doi: 10.1097/TA.0b013e31822a8fd5. No abstract available.
- Background Martinaud C, Ausset S, Deshayes AV, Cauet A, Demazeau N, Sailliol A. Use of freeze-dried plasma in French intensive care unit in Afghanistan. J Trauma. 2011 Dec;71(6):1761-4; discussion 1764-5. doi: 10.1097/TA.0b013e31822f1285.
- Background Sailliol A, Martinaud C, Cap AP, Civadier C, Clavier B, Deshayes AV, Mendes AC, Pouget T, Demazeau N, Chueca M, Martelet FR, Ausset S. The evolving role of lyophilized plasma in remote damage control resuscitation in the French Armed Forces Health Service. Transfusion. 2013 Jan;53 Suppl 1:65S-71S. doi: 10.1111/trf.12038.
- Background Martinaud C, Civadier C, Ausset S, Verret C, Deshayes AV, Sailliol A. In vitro hemostatic properties of French lyophilized plasma. Anesthesiology. 2012 Aug;117(2):339-46. doi: 10.1097/ALN.0b013e3182608cdd.
- Background Glassberg E, Nadler R, Gendler S, Abramovich A, Spinella PC, Gerhardt RT, Holcomb JB, Kreiss Y. Freeze-dried plasma at the point of injury: from concept to doctrine. Shock. 2013 Dec;40(6):444-50. doi: 10.1097/SHK.0000000000000047.
- Background Brown JB, Guyette FX, Neal MD, Claridge JA, Daley BJ, Harbrecht BG, Miller RS, Phelan HA, Adams PW, Early BJ, Peitzman AB, Billiar TR, Sperry JL. Taking the Blood Bank to the Field: The Design and Rationale of the Prehospital Air Medical Plasma (PAMPer) Trial. Prehosp Emerg Care. 2015 Jul-Sep;19(3):343-50. doi: 10.3109/10903127.2014.995851. Epub 2015 Feb 6.
- Background Kim BD, Zielinski MD, Jenkins DH, Schiller HJ, Berns KS, Zietlow SP. The effects of prehospital plasma on patients with injury: a prehospital plasma resuscitation. J Trauma Acute Care Surg. 2012 Aug;73(2 Suppl 1):S49-53. doi: 10.1097/TA.0b013e31826060ff.
- Background Chapman MP, Moore EE, Moore HB, Gonzalez E, Morton AP, Chandler J, Fleming CD, Ghasabyan A, Silliman CC, Banerjee A, Sauaia A. The "Death Diamond": Rapid thrombelastography identifies lethal hyperfibrinolysis. J Trauma Acute Care Surg. 2015 Dec;79(6):925-9. doi: 10.1097/TA.0000000000000871.
- Results Floccard B, Rugeri L, Faure A, Saint Denis M, Boyle EM, Peguet O, Levrat A, Guillaume C, Marcotte G, Vulliez A, Hautin E, David JS, Negrier C, Allaouchiche B. Early coagulopathy in trauma patients: an on-scene and hospital admission study. Injury. 2012 Jan;43(1):26-32. doi: 10.1016/j.injury.2010.11.003. Epub 2010 Nov 26.
- Results Borgman MA, Spinella PC, Perkins JG, Grathwohl KW, Repine T, Beekley AC, Sebesta J, Jenkins D, Wade CE, Holcomb JB. The ratio of blood products transfused affects mortality in patients receiving massive transfusions at a combat support hospital. J Trauma. 2007 Oct;63(4):805-13. doi: 10.1097/TA.0b013e3181271ba3.
- Results de Biasi AR, Stansbury LG, Dutton RP, Stein DM, Scalea TM, Hess JR. Blood product use in trauma resuscitation: plasma deficit versus plasma ratio as predictors of mortality in trauma (CME). Transfusion. 2011 Sep;51(9):1925-32. doi: 10.1111/j.1537-2995.2010.03050.x. Epub 2011 Feb 18.
- Results Peltan ID, Vande Vusse LK, Maier RV, Watkins TR. An International Normalized Ratio-Based Definition of Acute Traumatic Coagulopathy Is Associated With Mortality, Venous Thromboembolism, and Multiple Organ Failure After Injury. Crit Care Med. 2015 Jul;43(7):1429-38. doi: 10.1097/CCM.0000000000000981.
- Results Holcomb JB, Tilley BC, Baraniuk S, Fox EE, Wade CE, Podbielski JM, del Junco DJ, Brasel KJ, Bulger EM, Callcut RA, Cohen MJ, Cotton BA, Fabian TC, Inaba K, Kerby JD, Muskat P, O'Keeffe T, Rizoli S, Robinson BR, Scalea TM, Schreiber MA, Stein DM, Weinberg JA, Callum JL, Hess JR, Matijevic N, Miller CN, Pittet JF, Hoyt DB, Pearson GD, Leroux B, van Belle G; PROPPR Study Group. Transfusion of plasma, platelets, and red blood cells in a 1:1:1 vs a 1:1:2 ratio and mortality in patients with severe trauma: the PROPPR randomized clinical trial. JAMA. 2015 Feb 3;313(5):471-82. doi: 10.1001/jama.2015.12.
- Results Sunde GA, Vikenes B, Strandenes G, Flo KC, Hervig TA, Kristoffersen EK, Heltne JK. Freeze dried plasma and fresh red blood cells for civilian prehospital hemorrhagic shock resuscitation. J Trauma Acute Care Surg. 2015 Jun;78(6 Suppl 1):S26-30. doi: 10.1097/TA.0000000000000633.
- Results Moore HB, Moore EE, Morton AP, Gonzalez E, Fragoso M, Chapman MP, Dzieciatkowska M, Hansen KC, Banerjee A, Sauaia A, Silliman CC. Shock-induced systemic hyperfibrinolysis is attenuated by plasma-first resuscitation. J Trauma Acute Care Surg. 2015 Dec;79(6):897-903; discussion 903-4. doi: 10.1097/TA.0000000000000792.
- Results Rugeri L, Levrat A, David JS, Delecroix E, Floccard B, Gros A, Allaouchiche B, Negrier C. Diagnosis of early coagulation abnormalities in trauma patients by rotation thrombelastography. J Thromb Haemost. 2007 Feb;5(2):289-95. doi: 10.1111/j.1538-7836.2007.02319.x. Epub 2006 Nov 16.
- Brunskill SJ, Disegna A, Wong H, Fabes J, Desborough MJ, Doree C, Davenport R, Curry N, Stanworth SJ. Blood transfusion strategies for major bleeding in trauma. Cochrane Database Syst Rev. 2025 Apr 24;4(4):CD012635. doi: 10.1002/14651858.CD012635.pub2.
- Jost D, Lemoine S, Lemoine F, Derkenne C, Beaume S, Lanoe V, Maurin O, Louis-Delauriere E, Delacote M, Dang-Minh P, Franchin-Frattini M, Bihannic R, Savary D, Levrat A, Baudouin C, Trichereau J, Salome M, Frattini B, Ha VHT, Jouffroy R, Seguineau E, Titreville R, Roquet F, Stibbe O, Vivien B, Verret C, Bignand M, Travers S, Martinaud C, Arock M, Raux M, Prunet B, Ausset S, Sailliol A, Tourtier JP; Prehospital Lyophilized Plasma (PREHO-PLYO) Study Group. Prehospital Lyophilized Plasma Transfusion for Trauma-Induced Coagulopathy in Patients at Risk for Hemorrhagic Shock: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2223619. doi: 10.1001/jamanetworkopen.2022.23619.
- Jost D, Lemoine S, Lemoine F, Lanoe V, Maurin O, Derkenne C, Franchin Frattini M, Delacote M, Seguineau E, Godefroy A, Hervault N, Delhaye L, Pouliquen N, Louis-Delauriere E, Trichereau J, Roquet F, Salome M, Verret C, Bihannic R, Jouffroy R, Frattini B, Hong Tuan Ha V, Dang-Minh P, Travers S, Bignand M, Martinaud C, Garrabe E, Ausset S, Prunet B, Sailliol A, Tourtier JP; PREHO-PLYO Study Group. French lyophilized plasma versus normal saline for post-traumatic coagulopathy prevention and correction: PREHO-PLYO protocol for a multicenter randomized controlled clinical trial. Trials. 2020 Jan 22;21(1):106. doi: 10.1186/s13063-020-4049-1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | French Lyophilized Plasma | Other / unclassified | — | — |
Indications
No indication recorded.