Pre-hospital Administration of Lyophilized Plasma for Post-traumatic Coagulopathy Treatment (PREHO-PLYO)
NCT ID: NCT02736812
Last Updated: 2020-01-07
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
140 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-04-01
Study Completion Date
2019-11-30
Brief Summary
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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.
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.
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Detailed Description
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In severe bleeding due to trauma, a fall in coagulation factors maintains and promotes bleeding. The plasma allows, through its contribution of coagulation factors, early prevention or correction of this post-traumatic coagulopathy.
This labile blood product has so far only been used in armed conflicts by military medical and surgical units deployed in External Operations (EXOP) to meet the logistical constraints of the operating environment and the need to have, without delay, therapeutic plasma to treat bleeding casualties. Unlike frozen plasma used in hospitals, FLYP is stored at room temperature and is reconstituted in less than 6 mins.
In the civilian world, FLYP could be used by health institutions who have major logistical difficulties which do not allow them to ensure a cold chain of sub-zero temperatures, or in extreme emergency situations with the need for an immediate therapeutic plasma supply. In this second indication, FLYP should be used until the fresh frozen plasma is thawed and available. Its use in pre-hospital situations is also justified due to its immediate availability and storage conditions.
FLYP is sterile and is in powder-form with a residual humidity not exceeding 2%. It is packaged in a sterile and pyrogenic glass vial.
The main objective is 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 coagulopathy.
The secondary objectives consist in assessing the following outcomes :
(1) the need for massive transfusion (3) the ICU length of stay (4) the survival rate on day 30 (5) FLYP prehospital usability in civilian population (the compilation of technical and logistical difficulties encountered with administration of FLYP) (6) the Prothrombin time (PT) at hospital admission. Normal values for PT are 70 - 130%.
(7) the fibrinogen level at hospital admission (8) the variation in the level of PT, between the pre-hospital setting and the hospital admission .
(9) the variation in the level of INR, between the pre-hospital setting and the hospital admission .
(10) the variation in the fibrinogen level between the pre-hospital setting and the hospital admission .
Method
The attribution of the experimental treatment (FLYP or saline), to each patient who will receive a treatment numbered from 1 to 140, was carried out in advance using STATA 14.0 software.
Type of randomisation : randomisation in blocks of 2, stratified by center.
Treatments are allocated to participants in each "pre-hospital" center by ascending number.
Participants and investigators are therefore not blinded to the allocated treatment.However, the statistical analysis is planned to be carried out as a blind study regarding knowledge of the allocated treatment.
The planned experimental design is identical for each pre-hospital investigation centre.
Care of a patient in traumatic hemorrhagic shock is identical from one investigating centre to another: it is based on formalized expert recommendations on hemorrhagic shock resuscitation.
Determination of the number of subjects required
Coagulation factors were measured in a pre-after study in 2010 in the army in severely traumatized patients. The "before" period consisted of an isotonic infusion of saline saline chlorine, the "after" period of FLYP transfusion. In total, the inclusion of 124 patients showed a significant difference between the two groups in terms of PT value. In the absence of any other data available at the time of writing the protocol, we have brought the number of subjects required to 140 (= 2X 70) according to a 10% in the follow-up.
There is no planned interim analysis.
The administration of the treatment in the study is stopped if any adverse event (AE) occurs (abnormal clinical manifestation,...) and the offending experimental treatment is retained. Usual care and corrective actions are continued in the field, during transport and at the receiving hospital. An independent oversight committee meeting is organized to discuss the stopping or the continuation of the study according to the nature of the AE.
Comparability of the 2 groups for the primary endpoint:
The median INR values are compared between the two groups, after adjustment on other variables if necessary.
Comparability of the 2 groups for the secondary endpoints:
* Transfusion requirement will be judged by the number of units transfused after arrival at the hospital: packed red blood cells (RBC), platelet concentrates, fibrinogen, coagulation factors and plasma. The transfusion requirement will be measured over a period of 24 to 48 hours.
* The median number of days in the ICU between the two groups will use the medians test
* Survival analysis up to 30 days will be based on the comparison of Kaplan-Meier curves, by the log-rank test, and a Cox model to estimate the role of administration of FLYP on survival, taking into account potential confounding factors.
* The usability of administering FLYP will be judged on the grounds of interruption or non-administration of the experimental treatment, depending on the ability to respect the procedure and the use of a Labile Blood Product according to the rules of good practice.
* The average differential (pre-hospital -hospital) of coagulation parameters between the two groups will be compared by an ANCOVA adjusted on other variables if needed.
INTERRUPTION OR STOPPING OF THE STUDY
The sponsor has the responsibility to report, to the national health authority , any serious and unexpected adverse events attributable to the labile blood product of cell therapy and/or protocol within 15 days (7 days in case of death and life-threatening situations).
In the case of occurrence of an incident, accident, or event, interruption of the study is planned after analysis and decision by the hemovigilance and safety committee of the study.
RISKS
A full report on the risks, the description of incidents, accidents and adverse events will be the subject of a chapter in the results section and also in the discussion.
FINANCING
Funding for the study is provided by the Health Department of the Army (promoter, following the acceptance of the study in the context of Clinical research projects in the Health service of armies).
DISCUSSION
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.
CONCLUSION
This is the first study that aims to assess the usability and efficiency of FLYP in prehospital situation.
This labile blood product has so far only been used in armed conflicts by military medical and surgical units deployed in External Operations (EXOP) to meet the logistical constraints of the operating environment and the need to have, without delay, therapeutic plasma to treat bleeding casualties. Unlike frozen plasma used in hospitals, FLYP is stored at room temperature and is reconstituted in less than 6 mins.
In the civilian world, FLYP could be used by health institutions who have major logistical difficulties which do not allow them to ensure a cold chain of sub-zero temperatures, or in extreme emergency situations with the need for an immediate therapeutic plasma supply. In this second indication, FLYP should be used until the fresh frozen plasma is thawed and available. Its use in pre-hospital situations is also justified due to its immediate availability and storage conditions.
FLYP is sterile and is in powder-form with a residual humidity not exceeding 2%. It is packaged in a sterile and pyrogenic glass vial.
The main objective is 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 coagulopathy.
The secondary objectives consist in assessing the following outcomes :
(1) the need for massive transfusion (3) the ICU length of stay (4) the survival rate on day 30 (5) FLYP prehospital usability in civilian population (the compilation of technical and logistical difficulties encountered with administration of FLYP) (6) the Prothrombin time (PT) at hospital admission. Normal values for PT are 70 - 130%.
(7) the fibrinogen level at hospital admission (8) the variation in the level of PT, between the pre-hospital setting and the hospital admission .
(9) the variation in the level of INR, between the pre-hospital setting and the hospital admission .
(10) the variation in the fibrinogen level between the pre-hospital setting and the hospital admission .
Method
The attribution of the experimental treatment (FLYP or saline), to each patient who will receive a treatment numbered from 1 to 140, was carried out in advance using STATA 14.0 software.
Type of randomisation : randomisation in blocks of 2, stratified by center.
Treatments are allocated to participants in each "pre-hospital" center by ascending number.
Participants and investigators are therefore not blinded to the allocated treatment.However, the statistical analysis is planned to be carried out as a blind study regarding knowledge of the allocated treatment.
The planned experimental design is identical for each pre-hospital investigation centre.
Care of a patient in traumatic hemorrhagic shock is identical from one investigating centre to another: it is based on formalized expert recommendations on hemorrhagic shock resuscitation.
Determination of the number of subjects required
Coagulation factors were measured in a pre-after study in 2010 in the army in severely traumatized patients. The "before" period consisted of an isotonic infusion of saline saline chlorine, the "after" period of FLYP transfusion. In total, the inclusion of 124 patients showed a significant difference between the two groups in terms of PT value. In the absence of any other data available at the time of writing the protocol, we have brought the number of subjects required to 140 (= 2X 70) according to a 10% in the follow-up.
There is no planned interim analysis.
The administration of the treatment in the study is stopped if any adverse event (AE) occurs (abnormal clinical manifestation,...) and the offending experimental treatment is retained. Usual care and corrective actions are continued in the field, during transport and at the receiving hospital. An independent oversight committee meeting is organized to discuss the stopping or the continuation of the study according to the nature of the AE.
Comparability of the 2 groups for the primary endpoint:
The median INR values are compared between the two groups, after adjustment on other variables if necessary.
Comparability of the 2 groups for the secondary endpoints:
* Transfusion requirement will be judged by the number of units transfused after arrival at the hospital: packed red blood cells (RBC), platelet concentrates, fibrinogen, coagulation factors and plasma. The transfusion requirement will be measured over a period of 24 to 48 hours.
* The median number of days in the ICU between the two groups will use the medians test
* Survival analysis up to 30 days will be based on the comparison of Kaplan-Meier curves, by the log-rank test, and a Cox model to estimate the role of administration of FLYP on survival, taking into account potential confounding factors.
* The usability of administering FLYP will be judged on the grounds of interruption or non-administration of the experimental treatment, depending on the ability to respect the procedure and the use of a Labile Blood Product according to the rules of good practice.
* The average differential (pre-hospital -hospital) of coagulation parameters between the two groups will be compared by an ANCOVA adjusted on other variables if needed.
INTERRUPTION OR STOPPING OF THE STUDY
The sponsor has the responsibility to report, to the national health authority , any serious and unexpected adverse events attributable to the labile blood product of cell therapy and/or protocol within 15 days (7 days in case of death and life-threatening situations).
In the case of occurrence of an incident, accident, or event, interruption of the study is planned after analysis and decision by the hemovigilance and safety committee of the study.
RISKS
A full report on the risks, the description of incidents, accidents and adverse events will be the subject of a chapter in the results section and also in the discussion.
FINANCING
Funding for the study is provided by the Health Department of the Army (promoter, following the acceptance of the study in the context of Clinical research projects in the Health service of armies).
DISCUSSION
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.
CONCLUSION
This is the first study that aims to assess the usability and efficiency of FLYP in prehospital situation.
Conditions
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Shock Hemorrhagic
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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French Lyophilized Plasma
receives French Lyophilized Plasma with the usual treatment for post traumatic hemorrhagic shock as given in the recommendations for best practice
Group Type
EXPERIMENTAL
French Lyophilized Plasma
Intervention Type
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
Normal Saline Solution
receives Normale Saline Solution with the usual treatment of post traumatic hemorrhagic shock as given in the recommendations for best practice
Group Type
ACTIVE_COMPARATOR
Normale Saline Solution
Intervention Type
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
Interventions
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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
Intervention Type
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
Intervention Type
BIOLOGICAL
Eligibility Criteria
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Inclusion Criteria
* hemorrhagic shock of traumatic origin
* \[Systolic Blood Pressure \<70 mmHg\] OR \[Shock index \> 1.1\]
* \[Systolic Blood Pressure \<70 mmHg\] 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)
* 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)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Bataillon des marins pompiers de Marseille, France
UNKNOWN
Sponsor Role
collaborator
Military Hospital Laveran,Marseille, France
UNKNOWN
Sponsor Role
collaborator
Samu of Marseille, France
UNKNOWN
Sponsor Role
collaborator
Samu of Lyon, France
UNKNOWN
Sponsor Role
collaborator
Lyon-South Hospital, France
UNKNOWN
Sponsor Role
collaborator
Hôpital Edouard Herriot
OTHER
Sponsor Role
collaborator
Fire Brigade Of Paris Emergency Medicine Dept
OTHER
Sponsor Role
collaborator
CH Annecy Genevois
OTHER
Sponsor Role
collaborator
Institut de Recherche Biomedicale des Armees
OTHER_GOV
Sponsor Role
collaborator
Marseille North Hospital, France
UNKNOWN
Sponsor Role
collaborator
Samu of Necker, Paris, France
UNKNOWN
Sponsor Role
collaborator
Samu of Annecy, France
UNKNOWN
Sponsor Role
collaborator
Military Hospital Percy , Clamart, France
UNKNOWN
Sponsor Role
collaborator
Military Hospital Begin, Saint-Mandé, France
UNKNOWN
Sponsor Role
collaborator
Centre de transfusion sanguine des Armées, Clamart, France
UNKNOWN
Sponsor Role
collaborator
Henri Mondor University Hospital
OTHER
Sponsor Role
collaborator
Samu of Beaujon, Clichy-La-Garenne, France
UNKNOWN
Sponsor Role
collaborator
Samu of Lariboisière, Paris, France
UNKNOWN
Sponsor Role
collaborator
Samu of Henri Mondor, Créteil, France
UNKNOWN
Sponsor Role
collaborator
Samu of Brest, Brest , France
UNKNOWN
Sponsor Role
collaborator
Samu of Pau , Pau , France
UNKNOWN
Sponsor Role
collaborator
French Defence Health Service
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Daniel Jost
Emergency Physician - Research Dept
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Jean-Pierre TOURTIER, Professor
Role: STUDY_CHAIR
Fire Brigade Of Paris Emergency Medicine Dept
Daniel JOST, MD
Role: PRINCIPAL_INVESTIGATOR
Fire Brigade Of Paris Emergency Medicine Dept
Anne SAILLIOL, Professor
Role: STUDY_CHAIR
Centre de Transfusion Sanguine des Armées
Catherine VERRET, MD
Role: STUDY_CHAIR
Institut de recherche biomedicale des armées
Locations
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Centre Hospitalier Annecy Genevois
Annecy, , France
Site Status
Samu 74 Annecy Genevois
Annecy, , France
Site Status
Samu de BREST
Brest, , France
Site Status
Hopital d'instruction des Armées PERCY
Clamart, , France
Site Status
Centre de Transfusion Sanguine des Armées
Clamart, , France
Site Status
Hopital Beaujon
Clichy, , France
Site Status
Henri Mondor University Hospital
Créteil, , France
Site Status
Hopital Kremlin Bicetre
Le Kremlin-Bicêtre, , France
Site Status
Centre Hospitalier EDOUARD HERRIOT
Lyon, , France
Site Status
Samu de LYON
Lyon, , France
Site Status
Centre Hospitalier LYON SUD
Lyon, , France
Site Status
Hopital d'Instruction des Armées LAVERAN
Marseille, , France
Site Status
Bataillon des marins-pompiers de Marseille
Marseille, , France
Site Status
Hopital Nord de Marseille
Marseille, , France
Site Status
Samu de Marseille
Marseille, , France
Site Status
Hopital Pitié Salpétrière
Paris, , France
Site Status
Hopital Europen Georges Pompidou
Paris, , France
Site Status
Samu de Paris
Paris, , France
Site Status
Fire Brigade Of Paris Emergency Medicine Dept
Paris, , France
Site Status
Smur Lariboisiere
Paris, , France
Site Status
Samu de PAU
Pau, , France
Site Status
Hopital des Instructions des Armées BEGIN
Saint-Mandé, , France
Site Status
Countries
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France
References
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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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2014RC04
Identifier Type: -
Identifier Source: org_study_id
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