Hemorrhagic ShockProHEMSNCT02784951
Use of Blood and Plasma in Norwegian Physician-staffed Helicopter Emergency Medical System
An observational study of Hemorrhagic Shock, run by Haukeland University Hospital at 9 sites in Norway.
Trial summary
The main objective of this study is to evaluate the use of RBC, FDP, WB in the treatment of exsanguinating patients by physician-staffed emergency medical services in Norway, with focus on prehospital transfusion complications and safety. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemorrhagic Shock
- What is being tested?
- Red blood cells (0Rh D-neg), Whole blood (O Rh D-neg K-neg) and Freeze dried plasma (LyoPlas)
- How many people
- 72 participants
- Where
- 9 sitesNorway
- Study dates
- 1 Jan 2016to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients (pediatric and adult) in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products by treating physician staffed emergency medical services.
Who may be able to join
- All patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products according to listed indicators below:
- Patients with mechanism of injury compatible with severe haemorrhage and/or haemorrhagic shock (e.g. penetrating torso injury, visible massive bleeding)
- Radial pulse > 100 beats/min or absent/weak radial pulse
- Systolic blood pressure (SBP) < 90 mmHg
- Altered mental status (reduced GCS) in the absence of head injury or known intoxication
Who cannot join
- Patients with known previous serious allergic reactions to blood product transfusions
- Patients who refuse blood products on religious grounds, e.g. Jehovah´s Witness
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Norway9 sites
Sørlandet Hospital HF
Arendal, 4809
Haukeland University Hospital
Bergen, 5021
Innlandet Hospital Trust
Brumunddal, 2380
Vestre Viken Hospital Trust
Drammen, 3004
Helse Førde
Førde, 6807
Oslo University Hospital
Oslo, 0450
Helse Stavanger HF
Stavanger, 8100
University Hospital of North Norway
Tromsø, 9038
St Olav University Hospital
Trondheim, 7006
About this study
Official title: Use of Blood and Plasma in Prehospital Haemorrhagic Shock - a Prospective, Observational Trial of Advanced Deployment of Blood Products in Norwegian Physician-staffed Helicopter Emergency Medical System
The main objective of this study is to evaluate the use of RBC, FDP, WB in the treatment of exsanguinating patients by physician-staffed emergency medical services in Norway, with focus on prehospital transfusion complications and safety.
Read the detailed description
This study evaluates prehospital transfusion therapy in exsanguinating patients treated by physician-staffed emergency medical services in Norway, with the following main questions:
- Are out-of-hospital transfusions associated with an increase in adverse transfusion events compared to inhospital transfusions?
II. Is out-of-hospital physician administration of plasma or blood products in exsanguinating patients feasible?
III. Are patients in need of blood product transfusion possible to identify and transfuse in the prehospital phase/environment?
IV. Are out-of-hospital transfusion practices associated with increased waste of blood products?
All patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products will be included, if they fulfill the listed criteria below:
- Patients with mechanism of injury compatible with severe haemorrhage and/or haemorrhagic shock (e.g. penetrating torso injury, visible massive bleeding)
- Radial pulse > 100 beats/min or absent/weak radial pulse
- Systolic blood pressure (SBP) < 90 mmHg
- Altered mental status (reduced GCS) in the absence of head injury or known intoxication
Patients with known previous serious allergic reactions to blood product transfusions or patients who refuse blood products on religious grounds (e.g. Jehovah´s Witness) will be excluded.
- Conditions
- Hemorrhagic Shock
- Being tested
- Red blood cells (0Rh D-neg), Whole blood (O Rh D-neg K-neg), Freeze dried plasma (LyoPlas)
- Medical subject headings
- Shock, Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red blood cells (0Rh D-neg)Drug
Also called RBC
Fresh produced RBC
Whole blood (O Rh D-neg K-neg)Drug
Also called WB
Fresh produced WB
Freeze dried plasma (LyoPlas)Drug
Also called FDP
(LyoPlas N-w (German Red Cross)
| Study group | Role | What they receive |
|---|---|---|
| Single group | Patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products, either red blood cells (RBC), freeze dried plasma (FDP) or whole blood (WB). Receives: Drug: Red blood cells (0Rh D-neg); Drug: Whole blood (O Rh D-neg K-neg); Drug: Freeze dried plasma (LyoPlas) |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse transfusion reactions
Fraction of patients with suspected adverse transfusion reactions after administration of plasma and/or blood products.
Measured: 24 hours
patients included
Fraction of patients fulfilling inclusion criteria with prehospital administration of blood products
Measured: 24 hours
units not used
Fraction of prepared plasma or blood units not used.
Measured: 24 hours
Secondary outcomes (14)
Number of adverse events
Number of adverse events (e.g. transfusion related complications or reactions (first 24 hrs))
Measured: 24 hours
Type of adverse events
Type of adverse events (e.g. transfusion related complications or reactions (first 24 hrs))
Measured: 24 hours
number of transfusion
Number of transfusions given prehospital and inhospital (first 24 hrs)
Measured: 24 hours
type of transfusion
type of transfusions given prehospital and inhospital (first 24 hrs)
Measured: 24 hours
Systolic blood pressure (SBP)
Systolic blood pressure (SBP) on scene and at admission hospital
Measured: 24 hours
heart rate (HR)
heart rate (HR) on scene and at admission hospital
Measured: 24 hours
Glasgow Coma Score (GCS)
Glasgow Coma Score (GCS) on scene and at admission hospital
Measured: 24 hours
Respiratory rate (RR)
Respiratory rate (RR) on scene and at admission hospital
Measured: 24 hours
Pulse oximeter (SPO2)
Pulse oximeter (SPO2) on scene and at admission hospital
Measured: 24 hours
response time (minutes)
Physician staffed emergency medical services response (in minutes) from dispatch to arrival on-scene
Measured: 24 hours
on-scene time (minutes)
Time (in minutes) from emergency medical services arrival on-scene until patients leaves the scene or is pronounced dead on-scene
Measured: 24 hours
transport time (minutes)
Time (in minutes) from the patients leaves the scene until patient arrives in hospital
Measured: 24 hours
Number of surgical interventions
Number of surgical interventions (first 24 hrs)
Measured: 24 hours
Type of surgical interventions
type of surgical interventions (first 24 hrs)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study start1 Jan 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemorrhagic ShockStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sykehuset Innlandet HF, Oslo University Hospital, Sorlandet Hospital HF, St. Olavs Hospital, Helse Forde, Helse Stavanger HF, University Hospital of North Norway, Vestre Viken Hospital Trust
- Responsible party
- Sponsor
- Investigators
- Hanne Klausen, MD, Study director, Medical Director, Kirurgisk Serviceklinikk, Haukeland Universitetssykehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784951
- Sponsor's protocol ID
- 2016/304/REK vest
- Acronym
- ProHEMS
- Status last verified
- Dec 2021
- First submitted
- 18 May 2016
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Sunde GA, Bjerkvig C, Bekkevold M, Kristoffersen EK, Strandenes G, Bruserud O, Apelseth TO, Heltne JK. Implementation of a low-titre whole blood transfusion program in a civilian helicopter emergency medical service. Scand J Trauma Resusc Emerg Med. 2022 Dec 9;30(1):65. doi: 10.1186/s13049-022-01051-z.
PubMed 36494743
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Blood and Plasma in Prehospital Haemorrhagic Shock - a Prospective, Observational Trial of Advanced Deployment of Blood Products in Norwegian Physician-staffed Helicopter Emergency Medical System
- ClinicalTrials.gov ID
- NCT02784951
- Acronym / sponsor ID
- ProHEMS / 2016/304/REK vest
- Conditions
- Hemorrhagic Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Sykehuset Innlandet HF, Oslo University Hospital, Sorlandet Hospital HF, St. Olavs Hospital, Helse Forde, Helse Stavanger HF, University Hospital of North Norway, Vestre Viken Hospital Trust
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to evaluate the use of RBC, FDP, WB in the treatment of exsanguinating patients by physician-staffed emergency medical services in Norway, with focus on prehospital transfusion complications and safety.
Detailed description
This study evaluates prehospital transfusion therapy in exsanguinating patients treated by physician-staffed emergency medical services in Norway, with the following main questions:
- Are out-of-hospital transfusions associated with an increase in adverse transfusion events compared to inhospital transfusions?
II. Is out-of-hospital physician administration of plasma or blood products in exsanguinating patients feasible?
III. Are patients in need of blood product transfusion possible to identify and transfuse in the prehospital phase/environment?
IV. Are out-of-hospital transfusion practices associated with increased waste of blood products?
All patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products will be included, if they fulfill the listed criteria below:
- Patients with mechanism of injury compatible with severe haemorrhage and/or haemorrhagic shock (e.g. penetrating torso injury, visible massive bleeding)
- Radial pulse > 100 beats/min or absent/weak radial pulse
- Systolic blood pressure (SBP) < 90 mmHg
- Altered mental status (reduced GCS) in the absence of head injury or known intoxication
Patients with known previous serious allergic reactions to blood product transfusions or patients who refuse blood products on religious grounds (e.g. Jehovah´s Witness) will be excluded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | – | Drug: Red blood cells (0Rh D-neg), Drug: Whole blood (O Rh D-neg K-neg), Drug: Freeze dried plasma (LyoPlas)Patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products, either red blood cells (RBC), freeze dried plasma (FDP) or whole blood (WB). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients (pediatric and adult) in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products by treating physician staffed emergency medical services.
Key inclusion criteria (5 listed)
- All patients in haemorrhagic shock needing volume replacement and receiving prehospital transfusion of blood products according to listed indicators below:
Key exclusion criteria (2 listed)
- Patients with known previous serious allergic reactions to blood product transfusions
- Patients who refuse blood products on religious grounds, e.g. Jehovah´s Witness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red blood cells (0Rh D-neg)Also: RBCFresh produced RBC | Drug | Single group |
| Whole blood (O Rh D-neg K-neg)Also: WBFresh produced WB | Drug | Single group |
| Freeze dried plasma (LyoPlas)Also: FDP(LyoPlas N-w (German Red Cross) | Drug | Single group |
Primary outcome
adverse transfusion reactions
Time frame: 24 hours
Fraction of patients with suspected adverse transfusion reactions after administration of plasma and/or blood products.
patients included
Time frame: 24 hours
Fraction of patients fulfilling inclusion criteria with prehospital administration of blood products
units not used
Time frame: 24 hours
Fraction of prepared plasma or blood units not used.
14 secondary outcomes
Number of adverse events
Time frame: 24 hours
Type of adverse events
Time frame: 24 hours
number of transfusion
Time frame: 24 hours
type of transfusion
Time frame: 24 hours
Systolic blood pressure (SBP)
Time frame: 24 hours
heart rate (HR)
Time frame: 24 hours
Glasgow Coma Score (GCS)
Time frame: 24 hours
Respiratory rate (RR)
Time frame: 24 hours
Pulse oximeter (SPO2)
Time frame: 24 hours
response time (minutes)
Time frame: 24 hours
on-scene time (minutes)
Time frame: 24 hours
transport time (minutes)
Time frame: 24 hours
Number of surgical interventions
Time frame: 24 hours
Type of surgical interventions
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Derived from this study: PubMed 36494743Sunde GA, Bjerkvig C, Bekkevold M, Kristoffersen EK, Strandenes G, Bruserud O, Apelseth TO, Heltne JK. Implementation of a low-titre whole blood transfusion program in a civilian helicopter emergency medical service. Scand J Trauma Resusc Emerg Med. 2022 Dec 9;30(1):65. doi: 10.1186/s13049-022-01051-z.
- Individual participant dataSharing planned: No
Related trials for Hemorrhagic Shock
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
RecruitingPhase 4
Adult Outpatient Linvoseltamab With Tocilizumab Prophylaxis to Mitigate the Risk of Cytokine Release Syndrome (CRS)
Relapsed/Refractory Multiple Myeloma (RRMM)
Enrolling by invitationObservational study
Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage
Hypofibrinogenemia, Hemorrhage
RecruitingPhase 4
The Safety of Simplified Tranexamic Acid Regimen
Trauma Coagulopathy, Hemorrhage
RecruitingPhase 2
Infliximab for Cytokine Release Syndrome Prophylaxis During Teclistamab or Talquetamab Therapy in Patients With Relapsed or Refractory Myeloma
Cytokine Release Syndrome, Recurrent Multiple Myeloma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanne Klausen, MD study director
Medical Director, Kirurgisk Serviceklinikk, Haukeland Universitetssykehus
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhagic Shock, run by Haukeland University Hospital at 9 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse transfusion reactions (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02784951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.