Rapid Administration of Blood by HEMS in Trauma

NCT03522636 | Unknown

• 1 other identifier: 20180001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Wounds and Injuries; Acute Coagulopathy; Trauma

Keywords

Prehospital transfusion; Trauma; Trauma induced coagulopathy

Outcome Measures

Primary Outcomes (1)

• Units of blood products used

  Transfusion units of red blood cells, plasma and platelets

  Time of injury to 24 hours

Secondary Outcomes (10)

• Prehospital time

  Time of injury to 24 hours

• Volume of pre-hospital fluids

  Time of injury to 24 hours

• Blood pressure on admission to trauma centre

  Time of injury to 24 hours

• Trauma-induced coagulopathy

  Time of injury to 24 hours

• Lactate concentration

  Admission to 24 hours

Study Arms (2)

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

Eligibility Criteria

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

You may qualify if:

• Physiological indications
• Hypotension with absent radial pulse
• Hypotension with systolic arterial blood pressure \< 100 mmHg
• Anatomical indications
• Penetrating thoracic and/or abdominal injuries with signs of severe bleeding
• Injuries to neck, groins and/or axilla with signs of severe bleeding
• Clinical signs of intraabdominal bleeding
• Unstable chest wall
• Unstable pelvis
• Closed and/or open fractures of two or more long bones (femur, tibia, humerus)
• Open fracture of at least one femur type OIII
• Open fracture of pelvis
• Partial and/or total amputation limb injury above knee and/or elbow with severe external blood loss
• Mechanism of injury (supporting indications)
• Human torso entrapped in the vehicle with need for extrication (thorax, abdomen, pelvis)

You may not qualify if:

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

Sponsors & Collaborators

• Zdravotnicka Zachranna Sluzba Kralovehradeckeho Kraje: lead
• University Hospital Hradec Kralove: collaborator

Study Sites (2)

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

NOT YET RECRUITING

Zdravotnicka zachranna sluzba Kralovehradeckeho kraje

Hradec Králové, 50012, Czechia

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Anatolij Truhlar, MD PhD FERC

  Zdravotnicka Zachranna Sluzba Kralovehradeckeho Kraje

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anatolij Truhlar, MD PhD FERC

CONTACT

00420606816818; truhlaran@zzskhk.cz

Jaromir Koci, MD PhD FACS

CONTACT

00420728898467‬; jaromir.koci@fnhk.cz

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director EMS

Study Record Dates

• First Submitted: March 31, 2018
• First Posted: May 11, 2018
• Study Start: June 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: December 1, 2019
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

CZ (2)