TraumaNCT01793428
Capillary Lactate and Transfusion Needs
An observational study of Trauma, run by University Hospital, Grenoble at 1 site in France.
Trial summary
13% of injured normotensive patients arriving in emergency unit need mass blood-transfusion of six or more units of packed Red Blood Cells. It is currently difficult to predict the need for such a mass blood-transfusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma
- What is being tested?
- Capillary lactate level
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2011to Feb 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults admitted in vital emergency unit due to severe trauma based on a local severity score. Patients are normotensive
Who may be able to join
- Adult admitted in vital emergency unit
- Severe trauma
- normotensive (Systolic Blood Pressure >90mmHg)
- patient subjected to capillary haemoglobin and glucose measurements
- patient beneficiary of social security
Who cannot join
- pregnant woman
- liver deficiency
- pre-hospital transfusion
- hypothermia below 35°C
- protected persons according to the law
- Nor epinephrine > 0.1gamma/kg/min
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Abilities for Transfusion Needs of Capillary Lactate Measure in Emergency for Injured Normotensive Patients
13% of injured normotensive patients arriving in emergency unit need mass blood-transfusion of six or more units of packed Red Blood Cells. It is currently difficult to predict the need for such a mass blood-transfusion. Indeed hemoglobin point of care testing (hemocue) and blood pressure can be normal during the first hours despite intensive bleeding.
It's well known that blood or arterial lactate measures correlate with trauma severity but these measures are not available in a pre-hospital setting. The investigators want to test whether capillary lactate measures also correlate with trauma severity and can therefore predicts earlier transfusion needs.
- Conditions
- Trauma
- Being tested
- Capillary lactate level
- Keywords
- adults admitted in vital emergency unit
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capillary lactate levelOther
Use of capillary sample to determine lactate level upon arrival at vital emergency unit and at 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Injured patient admitted in vital emergency unit | Not described Receives: Other: Capillary lactate level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion of 6 or more units of packed Red Blood Cells (RBC)
Measured: 48 hours
Secondary outcomes (7)
arterial lactate measures
Measured: upon arrival at the vital emergency unit
injury scores (ISS,SOFA)
Measured: 24h
transfusion of 4 units of packed RBC
Measured: 48 hours
blood lactate measure
Measured: upon arrival at vital emergency unit
Intensity of medical care
Body scan Central venous catheterisation arterial catheterisation
Measured: upon arrival at vital emergency unit
Bleeding Predictive Score
3 questions are asked to the doctor in emergency room. Could patient be admitted directly at the CT scan ? Do you think that the patient need transfusion ? If Yes : and how many units ? Do you think that the patient will be hospitalized in an intensive care unit after the emergency room?
Measured: upon arrival at vital emergency unit
Mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startAug 2011
- Primary completionFeb 2013
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 TraumaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Vinclair, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793428
- Sponsor's protocol ID
- 2012-19
- Status last verified
- Apr 2015
- First submitted
- 12 Feb 2013
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bouzat P, Schilte C, Vinclair M, Manhes P, Brun J, Bosson JL, Payen JF. Capillary lactate concentration on admission of normotensive trauma patients: a prospective study. Scand J Trauma Resusc Emerg Med. 2016 Jun 7;24:82. doi: 10.1186/s13049-016-0272-x.
PubMed 27267942
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Abilities for Transfusion Needs of Capillary Lactate Measure in Emergency for Injured Normotensive Patients
- ClinicalTrials.gov ID
- NCT01793428
- Acronym / sponsor ID
- 2012-19
- Conditions
- Trauma
- Keywords
- adults admitted in vital emergency unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2013 (actual)
- First posted
- 15 Feb 2013 (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.
13% of injured normotensive patients arriving in emergency unit need mass blood-transfusion of six or more units of packed Red Blood Cells. It is currently difficult to predict the need for such a mass blood-transfusion. Indeed hemoglobin point of care testing (hemocue) and blood pressure can be normal during the first hours despite intensive bleeding.
It's well known that blood or arterial lactate measures correlate with trauma severity but these measures are not available in a pre-hospital setting. The investigators want to test whether capillary lactate measures also correlate with trauma severity and can therefore predicts earlier transfusion needs.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injured patient admitted in vital emergency unit | – | Other: Capillary lactate level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults admitted in vital emergency unit due to severe trauma based on a local severity score. Patients are normotensive
Key inclusion criteria (5 listed)
- Adult admitted in vital emergency unit
- Severe trauma
- normotensive (Systolic Blood Pressure >90mmHg)
- patient subjected to capillary haemoglobin and glucose measurements
- patient beneficiary of social security
Key exclusion criteria (6 listed)
- pregnant woman
- liver deficiency
- pre-hospital transfusion
- hypothermia below 35°C
- protected persons according to the law
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 |
|---|---|---|
| Capillary lactate levelUse of capillary sample to determine lactate level upon arrival at vital emergency unit and at 2 hours | Other | Injured patient admitted in vital emergency unit |
Primary outcome
Transfusion of 6 or more units of packed Red Blood Cells (RBC)
Time frame: 48 hours
7 secondary outcomes
arterial lactate measures
Time frame: upon arrival at the vital emergency unit
injury scores (ISS,SOFA)
Time frame: 24h
transfusion of 4 units of packed RBC
Time frame: 48 hours
blood lactate measure
Time frame: upon arrival at vital emergency unit
Intensity of medical care
Time frame: upon arrival at vital emergency unit
Bleeding Predictive Score
Time frame: upon arrival at vital emergency unit
Mortality
Time frame: 28 days
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 3 Apr 2015.
- Derived from this study: PubMed 27267942Bouzat P, Schilte C, Vinclair M, Manhes P, Brun J, Bosson JL, Payen JF. Capillary lactate concentration on admission of normotensive trauma patients: a prospective study. Scand J Trauma Resusc Emerg Med. 2016 Jun 7;24:82. doi: 10.1186/s13049-016-0272-x.
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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.
Marc Vinclair, MD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, run by University Hospital, Grenoble at 1 site in France.
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 6 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 3 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Transfusion of 6 or more units of packed Red Blood Cells (RBC) (time frame: 48 hours). 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 NCT01793428, 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 3 Apr 2015.