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Rapid Administration of Blood by HEMS in Trauma (RABBIT)

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: NCT03522636
Recruitment Status : Unknown
Verified June 2018 by Anatolij Truhlar, MD, PhD, FERC, Zdravotnicka Zachranna Sluzba Kralovehradeckeho Kraje.
Recruitment status was:  Recruiting
First Posted : May 11, 2018
Last Update Posted : June 6, 2018
Sponsor:
Collaborator:
University Hospital Hradec Kralove
Information provided by (Responsible Party):
Anatolij Truhlar, MD, PhD, FERC, Zdravotnicka Zachranna Sluzba Kralovehradeckeho Kraje

Brief Summary:
Trauma is a leading cause of death among people younger than 44 years. Five million people worldwide die from trauma annually. Uncontrolled haemorrhage causing traumatic-haemorrhagic shock (THS) is the leading cause of potentially preventable deaths from severe trauma. Uncorrected hypervolaemia and prolonged shock cause severe tissue hypoperfusion, vital organ ischemia and subsequently acidosis. In up to one third of trauma patients, laboratory findings suggest traumatic induced coagulopathy, which is further triggered by loss or dilution of coagulation factors. These patients have a significantly increased morbidity and mortality compared to patients with similar injury patterns without coagulopathy. Minimizing the time to surgical control of haemorrhage is key in order to improve outcome. However, immediate and goal directed volume and coagulation resuscitation including use of blood transfusion is crucial to enable survival until definitive hospital care. The primary objective of this study will be to evaluate feasibility of prehospital administration of 1 unit of human plasma and 1 unit of red blood cells, and explore association of early prehospital transfusion with early outcomes in patients presenting with THS, severe bleeding or peri-arrest state who are matching indication criteria and are transported by Helicopter Emergency Medical Service. Results of clinical examinations and laboratory variables in a group of patients receiving prehospital transfusion will be compared to matched population of patients treated before blood has been available on board. Secondary aim of the study is to detect any potential logistical and/or organisational adverse effects, incl. cost-effectiveness, in a regional trauma system with prehospital times (time of injury to trauma centre) ranging from 45 to 75 minutes.

Condition or disease
Wounds and Injuries Acute Coagulopathy Trauma

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of Pre-hospital Blood Transfusion on Early Outcomes in Trauma Patients Transported by Physician-staffed HEMS (Helicopter Emergency Medical Service)
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : December 2019


Group/Cohort
Treatment
Prehospital blood products resuscitation up to 2 units of blood products as follows: 1 unit of packed human plasma and 1 unit of packed red blood cells
Historic control
No prehospital blood products available



Primary Outcome Measures :
  1. Units of blood products used [ Time Frame: Time of injury to 24 hours ]
    Transfusion units of red blood cells, plasma and platelets


Secondary Outcome Measures :
  1. Prehospital time [ Time Frame: Time of injury to 24 hours ]
    Prehospital time (time of injury to arrival at trauma centre)

  2. Volume of pre-hospital fluids [ Time Frame: Time of injury to 24 hours ]
    Volume of fluids (crystalloids) given until hospital admission

  3. Blood pressure on admission to trauma centre [ Time Frame: Time of injury to 24 hours ]
    Systolic and diastolic blood pressure on admission to trauma centre

  4. Trauma-induced coagulopathy [ Time Frame: Time of injury to 24 hours ]
    NR > 1.5 and coagulation variables measured viscoelastically by rotational thromboelastometry (ROTEM)

  5. Lactate concentration [ Time Frame: Admission to 24 hours ]
    Venous lactate concentration

  6. ICU stay [ Time Frame: Admission to discharge from acute care hospital or 1 month ]
    Days of stay at intensive care unit

  7. Days of mechanical ventillation [ Time Frame: Time of injury to discharge from acute care hospital or 1 month ]
    Days of mechanical ventillation

  8. Sepsis-related organ failure assessment (SOFA) score [ Time Frame: Admission to discharge from acute care hospital or 1 month ]
    Sepsis-related organ failure assessment (SOFA) score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems assisting in estimating the risk of morbidity and mortality

  9. Complications [ Time Frame: Time of injury to discharge from acute care hospital or 1 month ]
    Transfusion related reactions, logistical, and organisational complications

  10. 24 hour and 30 day mortality [ Time Frame: 24 hours and 1 month ]
    Trauma-related mortality between time of injury and up to discharge from acute care hospital or 1 month



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All injured patients treated by a physician-staffed HEMS team will be eligible for inclusion. Authorized on-scene HEMS physicians will be responsible to make decision to administer prehospital blood if one or more of the anatomical and/or physiological inclusion criteria are met. Prehospital transfusion will always be considered as a life-saving intervention.
Criteria

Inclusion Criteria:

  1. Physiological indications

    1. Hypotension with absent radial pulse
    2. Hypotension with systolic arterial blood pressure < 100 mmHg
  2. Anatomical indications

    1. Penetrating thoracic and/or abdominal injuries with signs of severe bleeding
    2. Injuries to neck, groins and/or axilla with signs of severe bleeding
    3. Clinical signs of intraabdominal bleeding
    4. Unstable chest wall
    5. Unstable pelvis
    6. Closed and/or open fractures of two or more long bones (femur, tibia, humerus)
    7. Open fracture of at least one femur type OIII
    8. Open fracture of pelvis
    9. Partial and/or total amputation limb injury above knee and/or elbow with severe external blood loss
  3. Mechanism of injury (supporting indications)

    1. Human torso entrapped in the vehicle with need for extrication (thorax, abdomen, pelvis)
    2. Fall from height of > 6 metres (on scene verification needed)
    3. Human torso (thorax, abdomen, pelvis) over-driven by a motor vehicle
    4. Human torso (thorax, abdomen, pelvis) compressed by a heavy object or animal

Exclusion Criteria:

  1. Absolute contraindications

    a. Traumatic cardiac arrest (TCA) from a blunt injury before decision to administer blood products. Any ROSC after resuscitation of TCA is not a contraindication.

  2. Relative contraindications

    1. Traumatic brain injury (TBI) caused by direct force towards head region (e.g. gunshot) without signs of injury to other systems or body areas
    2. Age under 15 years.
    3. Any other admitting hospital than trauma center of the University Hospital Hradec Kralove

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): NCT03522636


Contacts
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Contact: Anatolij Truhlar, MD PhD FERC 00420606816818 truhlaran@zzskhk.cz
Contact: Jaromir Koci, MD PhD FACS 00420728898467‬ jaromir.koci@fnhk.cz

Locations
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Czechia
University Hospital Hradec Kralove Not yet recruiting
Hradec Kralove, Czechia, 50005
Contact: Jaromir Koci, MD PhD FACS    00420728898467‬    jaromir.koci@fnhk.cz   
Contact: Jana Berkova, MD    00420606337353‬    jana.berkova@fnhk.cz   
Principal Investigator: Jaromir Koci, MD PhD FACS         
Sub-Investigator: Vit Rehacek, MD         
Sub-Investigator: Tomas Dedek, MD PhD         
Sub-Investigator: Jana Berkova, MD         
Sub-Investigator: Anatolij Truhlar, MD PhD FERC         
Zdravotnicka zachranna sluzba Kralovehradeckeho kraje Recruiting
Hradec Kralove, Czechia, 50012
Contact: Anatolij Truhlar, MD PhD FERC    00420606816818    truhlaran@zzskhk.cz   
Contact: Marek Dvorak, MD       dvorakma@zzskhk.cz   
Principal Investigator: Anatolij Truhlar, MD PhD FERC         
Sub-Investigator: Marek Dvorak, MD         
Sub-Investigator: Libor Seneta, MD         
Sponsors and Collaborators
Zdravotnicka Zachranna Sluzba Kralovehradeckeho Kraje
University Hospital Hradec Kralove
Investigators
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Principal Investigator: Anatolij Truhlar, MD PhD FERC Zdravotnicka Zachranna Sluzba Kralovehradeckeho Kraje
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Responsible Party: Anatolij Truhlar, MD, PhD, FERC, Medical Director EMS, Zdravotnicka Zachranna Sluzba Kralovehradeckeho Kraje
ClinicalTrials.gov Identifier: NCT03522636    
Other Study ID Numbers: 20180001
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anatolij Truhlar, MD, PhD, FERC, Zdravotnicka Zachranna Sluzba Kralovehradeckeho Kraje:
Prehospital transfusion
Trauma
Trauma induced coagulopathy
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Wounds and Injuries
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders