Pre-hospital Administration of Lyophilized Plasma for Post-traumatic Coagulopathy Treatment (PREHO-PLYO)

NCT02736812 | Completed Phase 3 DMC

• 1 other identifier: 2014RC04
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 22

Brief 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.

Conditions

Shock Hemorrhagic

Keywords

Randomized controlled trial; Lyophilized Plasma; Advanced Trauma Life Support Care

Outcome Measures

Primary Outcomes (1)

• the International Normalized Ratio level (international unit IU) at hospital admission

  1 day

Secondary Outcomes (16)

• number of plasma units administered at 24 and 48 hours

  48 hours

• Number of RBC Concentrates units administered at 24 and 48 hours

  48 hours

• Number of platelet concentrates units administered at 24 and 48 hours

  48 hours

• Total Intensive care unit of stay (days)

  30 days

• Survival

  30 days

Study Arms (2)

French Lyophilized Plasma

EXPERIMENTAL

receives French Lyophilized Plasma with the usual treatment for post traumatic hemorrhagic shock as given in the recommendations for best practice

Biological: French Lyophilized Plasma

Normal Saline Solution

ACTIVE COMPARATOR

receives Normale Saline Solution with the usual treatment of post traumatic hemorrhagic shock as given in the recommendations for best practice

Biological: Normale Saline Solution

Interventions

French Lyophilized Plasma BIOLOGICAL

During the pre-hospital phase, the main events related to this arm are * Blood samples taken before treatment (TP, fibrinogen, platelets, RBC, grouping) * Usual pre-hospital care according to recommendations in best practices * Administration of FLYP

French Lyophilized Plasma

Normale Saline Solution BIOLOGICAL

During the pre-hospital phase, the main events related to this arm are * Blood samples taken before treatment (TP, fibrinogen, platelets, RBC, grouping) * Usual pre-hospital care according to recommendations in best practices * Administration of Normale Saline Solution

Normal Saline Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hemorrhagic shock of traumatic origin
• \[Systolic Blood Pressure \<70 mmHg\] OR \[Shock index \> 1.1\]

You may not qualify if:

• Refusal to participate in the research
• Unaffiliated to a social welfare system
• Age under 18 years
• Privation of person's liberty
• Person subject to a safeguard measure of justice
• Pregnancy
• Allergy known to Amotosalen® and psoralen
• Contribution factor clotting other than Plyo
• Patient initialy in cardiac arrest
• Patient initially in cardiac arrest, followed by resumption of spontaneous circulation
• People who could not have blood sample (required for the primary endpoint)

Sponsors & Collaborators

• French Defence Health Service: lead
• Bataillon des marins pompiers de Marseille, France: collaborator
• Military Hospital Laveran,Marseille, France: collaborator
• Samu of Marseille, France: collaborator
• Samu of Lyon, France: collaborator
• Lyon-South Hospital, France: collaborator
• Hôpital Edouard Herriot: collaborator
• Fire Brigade Of Paris Emergency Medicine Dept: collaborator
• CH Annecy Genevois: collaborator
• Institut de Recherche Biomedicale des Armees: collaborator
• Marseille North Hospital, France: collaborator
• Samu of Necker, Paris, France: collaborator
• Samu of Annecy, France: collaborator
• Military Hospital Percy , Clamart, France: collaborator
• Military Hospital Begin, Saint-Mandé, France: collaborator
• Centre de transfusion sanguine des Armées, Clamart, France: collaborator
• Henri Mondor University Hospital: collaborator
• Samu of Beaujon, Clichy-La-Garenne, France: collaborator
• Samu of Lariboisière, Paris, France: collaborator
• Samu of Henri Mondor, Créteil, France: collaborator
• Samu of Brest, Brest , France: collaborator
• Samu of Pau , Pau , France: collaborator

Study Sites (22)

Centre Hospitalier Annecy Genevois

Annecy, 74370, France

Location

Samu 74 Annecy Genevois

Annecy, 74, France

Location

Samu de BREST

Brest, 29200, France

Location

Hopital d'instruction des Armées PERCY

Clamart, 92140, France

Location

Centre de Transfusion Sanguine des Armées

Clamart, 92, France

Location

Hopital Beaujon

Clichy, 92110, France

Location

Henri Mondor University Hospital

Créteil, France

Location

Hopital Kremlin Bicetre

Le Kremlin-Bicêtre, 94275, France

Location

Centre Hospitalier EDOUARD HERRIOT

Lyon, 69003, France

Location

Samu de LYON

Lyon, 69003, France

Location

Centre Hospitalier LYON SUD

Lyon, 69495, France

Location

Hopital d'Instruction des Armées LAVERAN

Marseille, 13013, France

Location

Bataillon des marins-pompiers de Marseille

Marseille, 13233, France

Location

Hopital Nord de Marseille

Marseille, 13915, France

Location

Samu de Marseille

Marseille, 13915, France

Location

Hopital Pitié Salpétrière

Paris, 75013, France

Location

Hopital Europen Georges Pompidou

Paris, 75015, France

Location

Samu de Paris

Paris, 75015, France

Location

Fire Brigade Of Paris Emergency Medicine Dept

Paris, 75017, France

Location

Smur Lariboisiere

Paris, 75475, France

Location

Samu de PAU

Pau, 64000, France

Location

Hopital des Instructions des Armées BEGIN

Saint-Mandé, 94, France

Location

Related Publications (22)

• 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.

  PMID: 22094519 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.

  PMID: 21909011 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.

  PMID: 12813333 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.

  PMID: 21986756 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.

  PMID: 22182886 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.

  PMID: 23301975 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.

  PMID: 22739764 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.

  PMID: 24089000 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.

  PMID: 25658881 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.

  PMID: 22847094 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.

  PMID: 26488324 BACKGROUND

• 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.

  PMID: 21112053 RESULT

• 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.

  PMID: 18090009 RESULT

• 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.

  PMID: 21332727 RESULT

• 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.

  PMID: 25816119 RESULT

• 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.

  PMID: 25647203 RESULT

• 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.

  PMID: 26002260 RESULT

• 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.

  PMID: 26680132 RESULT

• 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.

  PMID: 17109736 RESULT

• 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.

  PMID: 40271704 DERIVED

• 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.

  PMID: 35881397 DERIVED

• 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.

  PMID: 31969168 DERIVED

MeSH Terms

Conditions

Shock, Hemorrhagic

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Jean-Pierre TOURTIER, Professor

  Fire Brigade Of Paris Emergency Medicine Dept

  STUDY CHAIR

• Daniel JOST, MD

  Fire Brigade Of Paris Emergency Medicine Dept

  PRINCIPAL INVESTIGATOR

• Anne SAILLIOL, Professor

  Centre de Transfusion Sanguine des Armées

  STUDY CHAIR

• Catherine VERRET, MD

  Institut de recherche biomedicale des armées

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Physician - Research Dept

Study Record Dates

• First Submitted: March 27, 2016
• First Posted: April 13, 2016
• Study Start: April 1, 2016
• Primary Completion: October 31, 2019
• Study Completion: November 30, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (22)