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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02736812
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : January 7, 2020
Sponsor:
Collaborators:
Bataillon des marins pompiers de Marseille, France
Military Hospital Laveran,Marseille, France
Samu of Marseille, France
Samu of Lyon, France
Lyon-South Hospital, France
Hôpital Edouard Herriot
Fire Brigade Of Paris Emergency Medicine Dept
CH Annecy Genevois
Institut de Recherche Biomedicale des Armees
Marseille North Hospital, France
Samu of Necker, Paris, France
Samu of Annecy, France
Military Hospital Percy , Clamart, France
Military Hospital Begin, Saint-Mandé, France
Centre de transfusion sanguine des Armées, Clamart, France
Henri Mondor University Hospital
Samu of Beaujon, Clichy-La-Garenne, France
Samu of Lariboisière, Paris, France
Samu of Henri Mondor, Créteil, France
Samu of Brest, Brest , France
Samu of Pau , Pau , France
Information provided by (Responsible Party):
Daniel Jost, Fire Brigade Of Paris Emergency Medicine Dept

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.


Condition or disease Intervention/treatment Phase
Shock Hemorrhagic Biological: French Lyophilized Plasma Biological: Normale Saline Solution Phase 3

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interest of Pre-hospital Administration of Lyophilized Plasma to Prevent or Treat Coagulopathy Associated With Post-traumatic Hemorrhagic Shock (PREHO-PLYO Study )
Study Start Date : April 1, 2016
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: French Lyophilized Plasma
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

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

Active Comparator: Normal Saline Solution
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

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




Primary Outcome Measures :
  1. the International Normalized Ratio level (international unit IU) at hospital admission [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. number of plasma units administered at 24 and 48 hours [ Time Frame: 48 hours ]
  2. Number of RBC Concentrates units administered at 24 and 48 hours [ Time Frame: 48 hours ]
  3. Number of platelet concentrates units administered at 24 and 48 hours [ Time Frame: 48 hours ]
  4. Total Intensive care unit of stay (days) [ Time Frame: 30 days ]
  5. Survival [ Time Frame: 30 days ]
  6. FLYP prehospital usability in civilian population (questionnaire) [ Time Frame: 30 days ]
    Compilation of technical and logistical difficulties encountered before, during and after administration of FLYP

  7. Fibrinogen level (grams) [ Time Frame: 1 day ]
  8. Prothrombin level change (percentage) [ Time Frame: 48 hours ]
    The difference in the level of Prothrombin (PT), between prehospital and hospital admission

  9. the level of coagulation factors (international unit IU) at hospital admission [ Time Frame: 1 day ]
  10. Quantity of fibrinogen administered in grams at 24 and 48 hours [ Time Frame: 48 hours ]
  11. quantity of coagulation factors administered (international units IU) [ Time Frame: 48 hours ]
    quantity of coagulation factors administered (international units IU)

  12. Thromboelastometry median clotting time (CT) (minutes). [ Time Frame: 1 hour ]
    Time in minutes and secondes for each step coming from rotational elastometry

  13. Thromboelastometry median Clot Formation Time (CFT) in minutes and seconds [ Time Frame: 1 hour ]
    Time in minutes and seconds for each step coming from rotational elastometry

  14. Thromboelastometry median maximal lysis (ML) time in minutes ans seconds [ Time Frame: 1 hour ]
    Time in minutes and seconds for each step coming from rotational elastometry

  15. Thromboelastometry alpha angle (degrees) [ Time Frame: 1 hour ]
    measure unit : degrees

  16. Thromboelastometry median Maximal Clot Firmness (MCF) time in minutes and seconds [ Time Frame: 1 hour ]
    Time in minutes and seconds for each step coming from rotational elastometry



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736812


Locations
Show Show 22 study locations
Sponsors and Collaborators
French Defence Health Service
Bataillon des marins pompiers de Marseille, France
Military Hospital Laveran,Marseille, France
Samu of Marseille, France
Samu of Lyon, France
Lyon-South Hospital, France
Hôpital Edouard Herriot
Fire Brigade Of Paris Emergency Medicine Dept
CH Annecy Genevois
Institut de Recherche Biomedicale des Armees
Marseille North Hospital, France
Samu of Necker, Paris, France
Samu of Annecy, France
Military Hospital Percy , Clamart, France
Military Hospital Begin, Saint-Mandé, France
Centre de transfusion sanguine des Armées, Clamart, France
Henri Mondor University Hospital
Samu of Beaujon, Clichy-La-Garenne, France
Samu of Lariboisière, Paris, France
Samu of Henri Mondor, Créteil, France
Samu of Brest, Brest , France
Samu of Pau , Pau , France
Investigators
Layout table for investigator information
Study Chair: Jean-Pierre TOURTIER, Professor Fire Brigade Of Paris Emergency Medicine Dept
Principal Investigator: Daniel JOST, MD Fire Brigade Of Paris Emergency Medicine Dept
Study Chair: Anne SAILLIOL, Professor Centre de Transfusion Sanguine des Armées
Study Chair: Catherine VERRET, MD Institut de recherche biomedicale des armées

Publications of Results:

Other Publications:

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Responsible Party: Daniel Jost, Emergency Physician - Research Dept, Fire Brigade Of Paris Emergency Medicine Dept
ClinicalTrials.gov Identifier: NCT02736812    
Other Study ID Numbers: 2014RC04
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Daniel Jost, Fire Brigade Of Paris Emergency Medicine Dept:
Randomized controlled trial
Lyophilized Plasma
Advanced Trauma Life Support Care
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Shock
Shock, Hemorrhagic
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hemorrhage
Pharmaceutical Solutions