TraumaNCT02772653
Evaluation of Resuscitation Markers in Trauma Patients
An observational study of Trauma and Hypovolemic Shock, run by Andrea Campos-Serra at 1 site in Spain.
Trial summary
Severe trauma patients have an elevated risk of multiple organ failure and death. In order to increase survival possibilities the initial treatment must be focused into resuscitation from shock. Traditionally the most common resuscitation markers used are vital signs and urine output. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Hypovolemic Shock
- What is being tested?
- Blood Lactate, Blood Base Excess and Blood B-type Natriuretic Peptide
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- May 2016to 26 Mar 2019
- 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: Severe trauma patients admitted at Corporacio Sanitaria Parc Tauli
Who may be able to join
- Pre-hospital Priority 0 protocol activation:
- Glasgow coma scale < 14
- Systolic blood pressure < 90 mmHg
- Respiratory rate < 10 or > 29 breaths per minute
- Absent peripheral pulses
- Pre-hospital Priority 1 protocol activation:
Show all 14Show fewer
- All penetratin injuries to head, neck, torso and extremities proximal to elbow and knee
- Flail chest
- Two or more proximal long-bone fractures
- Crushed, degloved or mangled extremity
- Amputation proximal to wrist and ankle
- Pelvic fracture
- Open or depressed skull fracture
- Paralysis
Who cannot join
- Hospitalization < 24 hours ( transport of the patient to an other trauma center)
- Patients transported from an other hospital (first hours of medical support done elsewhere)
Trial locations and contacts
1 site in 1 country.
About this study
Severe trauma patients have an elevated risk of multiple organ failure and death. In order to increase survival possibilities the initial treatment must be focused into resuscitation from shock. Traditionally the most common resuscitation markers used are vital signs and urine output. Unfortunately, many patients might present normal vital signs, but still undergo a compensated shock with persistent acidosis, hence being able to develop multiple organ failure and death. Consequently, it is important to define better resuscitation markers for these patients.
This investigation project consists in an observational prospective study, performed by a multidisciplinary team, in which different resuscitation markers are evaluated in severe trauma patients. There will be a specific timing (1st, 8th and 24th hours from arrival) evaluation of different markers: hemodynamic (vital signs, urine output, etc); analytical (lactate, base excess, natriuretic atrial peptide); tissue perfusion markers (NIRS); microcirculation markers (videomicroscopy) and coagulopathy markers (thromboelastometry). There will be a registry of total volume administration; blood cell transfusions and vasoactive drug requirements. Each marker will be evaluated in relation to mortality; multiple organ failure; massive transfusion protocol activation; blood cell transfusion requirement; surgical control of bleeding requirement and emergent arteriographic embolization. The objective of this study is to demonstrate which of these markers is better to predict hemodynamic evolution of severe trauma patients and might become a guide for resuscitation in the future.
- Conditions
- Trauma, Hypovolemic Shock
- Being tested
- Blood Lactate, Blood Base Excess, Blood B-type Natriuretic Peptide, Blood Thromboelastometry (ROTEM), Near-infrared spectroscopy
- Keywords
- Microcirculation, Videomicroscopy, Spectroscopy, Near-Infrared, B-Type Natriuretic Peptide, Thromboelastometry, Trauma, Resuscitation, Hypovolemic shock
- Medical subject headings
- Wounds and Injuries, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood LactateOther
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Blood Base ExcessOther
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Blood B-type Natriuretic PeptideOther
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Blood Thromboelastometry (ROTEM)Other
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Near-infrared spectroscopyOther
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Sublingual videomicroscopyOther
Analyzed at the 1rst, 8th and 24th hour from hospital admission
| Study group | Role | What they receive |
|---|---|---|
| Severe trauma patients | No interventions are done. It's a prospective and descriptive observational study where different markers are analyzed:
* Blood Lactate levels
* Blood Base Excess levels
* Blood B-type Natriuretic Peptide levels
* Blood Thromboelastometry (ROTEM) alterations
* Near-infrared spectroscopy alterations
* Sublingual videomicroscopy alterations
All these markers are analyzed at the 1rst, 8th and 24th hour from hospital admission. Receives: Other: Blood Lactate; Other: Blood Base Excess; Other: Blood B-type Natriuretic Peptide; Other: Blood Thromboelastometry (ROTEM); Other: Near-infrared spectroscopy; Other: Sublingual videomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death of the patient
Measured: Through study completion, an average of 1-2 years
Secondary outcomes (5)
Multiple organ dysfunction (Multiple Organ Dysfunction Score)
Marshall's score (MODS Score) consist on the analysis of 6 systems through different descriptors, those descriptors include: a) the respiratory system (pO2/FIO2 ratio); b) the renal system (serum creatinine concentration); c) the hepatic system (serum bilirrubine concentration); d) the hematologic system (platelet count); and e) the central nervous system (Glasgow Coma Scale); and f) the cardiovascular system (pressure adjusted heart rate). The cardiovascular system descriptor is calculated as the product of the heart rate and the ratio of central venous pressure to mean arterial pressure. All these descriptors will be measured during the first 24h from hospital admission.
Measured: Through study completion, an average of 1-2 years
Blood cell transfusion
Need for blood cell transfusion for patients
Measured: Through study completion, an average of 1-2 years
Activation of the Massive blood transfusion protocol
Need for massive transfusion protocol activation on patients with suspicion of active bleeding
Measured: At hospital admission
Surgical intervention for bleeding control
Need for surgical control on patients with active bleeding
Measured: Through study completion, an average of 1-2 years
Arteriographic embolization for bleeding control
Need for arteriographic embolization on patients with active bleeding
Measured: Through study completion, an average of 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startMay 2016
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrea Campos-Serra
- Sponsor type
- University, hospital or other
- Collaborators
- Corporacion Parc Tauli
- Responsible party
- Sponsor-investigator, Andrea Campos-Serra, Corporacion Parc Tauli
- Investigators
- Andrea Campos-Serra, MD, Principal investigator, Corporacion Sanitaria Parc TauliSalvador Navarro-Soto, MD, PhD, Study director, Corporacion Sanitaria Parc TauliSandra Montmany-Vioque, MD, PhD, Study director, Corporacion Sanitaria Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772653
- Sponsor's protocol ID
- CSPT-CG-PPT1
- Status last verified
- May 2019
- First submitted
- 7 May 2016
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Campos-Serra A, Mesquida J, Montmany-Vioque S, Rebasa-Cladera P, Barquero-Lopez M, Cidoncha-Secilla A, Llorach-Perucho N, Morales-Codina M, Puyana JC, Navarro-Soto S. Alterations in tissue oxygen saturation measured by near-infrared spectroscopy in trauma patients after initial resuscitation are associated with occult shock. Eur J Trauma Emerg Surg. 2023 Feb;49(1):307-315. doi: 10.1007/s00068-022-02068-w. Epub 2022 Sep 2.
PubMed 36053289
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Resuscitation Markers in Trauma Patients
- ClinicalTrials.gov ID
- NCT02772653
- Acronym / sponsor ID
- CSPT-CG-PPT1
- Conditions
- Trauma, Hypovolemic Shock
- Keywords
- Microcirculation, Videomicroscopy, Spectroscopy, Near-Infrared, B-Type Natriuretic Peptide, Thromboelastometry, Trauma, Resuscitation, Hypovolemic shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Andrea Campos-SerraUniversity, hospital or other
- Collaborators
- Corporacion Parc Tauli
- Study start
- May 2016
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 13 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.
Severe trauma patients have an elevated risk of multiple organ failure and death. In order to increase survival possibilities the initial treatment must be focused into resuscitation from shock. Traditionally the most common resuscitation markers used are vital signs and urine output. Unfortunately, many patients might present normal vital signs, but still undergo a compensated shock with persistent acidosis, hence being able to develop multiple organ failure and death. Consequently, it is important to define better resuscitation markers for these patients.
This investigation project consists in an observational prospective study, performed by a multidisciplinary team, in which different resuscitation markers are evaluated in severe trauma patients. There will be a specific timing (1st, 8th and 24th hours from arrival) evaluation of different markers: hemodynamic (vital signs, urine output, etc); analytical (lactate, base excess, natriuretic atrial peptide); tissue perfusion markers (NIRS); microcirculation markers (videomicroscopy) and coagulopathy markers (thromboelastometry). There will be a registry of total volume administration; blood cell transfusions and vasoactive drug requirements. Each marker will be evaluated in relation to mortality; multiple organ failure; massive transfusion protocol activation; blood cell transfusion requirement; surgical control of bleeding requirement and emergent arteriographic embolization. The objective of this study is to demonstrate which of these markers is better to predict hemodynamic evolution of severe trauma patients and might become a guide for resuscitation in the future.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe trauma patients | – | Other: Blood Lactate, Other: Blood Base Excess, Other: Blood B-type Natriuretic Peptide, Other: Blood Thromboelastometry (ROTEM), Other: Near-infrared spectroscopy, Other: Sublingual videomicroscopyNo interventions are done. It's a prospective and descriptive observational study where different markers are analyzed: * Blood Lactate levels * Blood Base Excess levels * Blood B-type Natriuretic Peptide levels * Blood Thromboelastometry (ROTEM) alterations * Near-infrared spectroscopy alterations * Sublingual videomicroscopy alterations All these markers are analyzed at the 1rst, 8th and 24th hour from hospital admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Severe trauma patients admitted at Corporacio Sanitaria Parc Tauli
Key inclusion criteria (14 listed)
- Pre-hospital Priority 0 protocol activation:
- Glasgow coma scale < 14
- Systolic blood pressure < 90 mmHg
- Respiratory rate < 10 or > 29 breaths per minute
- Absent peripheral pulses
Key exclusion criteria (2 listed)
- Hospitalization < 24 hours ( transport of the patient to an other trauma center)
- Patients transported from an other hospital (first hours of medical support done elsewhere)
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 |
|---|---|---|
| Blood LactateAnalyzed at the 1rst, 8th and 24th hour from hospital admission | Other | Severe trauma patients |
| Blood Base ExcessAnalyzed at the 1rst, 8th and 24th hour from hospital admission | Other | Severe trauma patients |
| Blood B-type Natriuretic PeptideAnalyzed at the 1rst, 8th and 24th hour from hospital admission | Other | Severe trauma patients |
| Blood Thromboelastometry (ROTEM)Analyzed at the 1rst, 8th and 24th hour from hospital admission | Other | Severe trauma patients |
| Near-infrared spectroscopyAnalyzed at the 1rst, 8th and 24th hour from hospital admission | Other | Severe trauma patients |
| Sublingual videomicroscopyAnalyzed at the 1rst, 8th and 24th hour from hospital admission | Other | Severe trauma patients |
Primary outcome
Mortality
Time frame: Through study completion, an average of 1-2 years
Death of the patient
5 secondary outcomes
Multiple organ dysfunction (Multiple Organ Dysfunction Score)
Time frame: Through study completion, an average of 1-2 years
Blood cell transfusion
Time frame: Through study completion, an average of 1-2 years
Activation of the Massive blood transfusion protocol
Time frame: At hospital admission
Surgical intervention for bleeding control
Time frame: Through study completion, an average of 1-2 years
Arteriographic embolization for bleeding control
Time frame: Through study completion, an average of 1-2 years
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 14 May 2019.
- Derived from this study: PubMed 36053289Campos-Serra A, Mesquida J, Montmany-Vioque S, Rebasa-Cladera P, Barquero-Lopez M, Cidoncha-Secilla A, Llorach-Perucho N, Morales-Codina M, Puyana JC, Navarro-Soto S. Alterations in tissue oxygen saturation measured by near-infrared spectroscopy in trauma patients after initial resuscitation are associated with occult shock. Eur J Trauma Emerg Surg. 2023 Feb;49(1):307-315. doi: 10.1007/s00068-022-02068-w. Epub 2022 Sep 2.
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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.
Andrea Campos-Serra, MD principal investigator
Corporacion Sanitaria Parc Tauli
Salvador Navarro-Soto, MD, PhD study director
Corporacion Sanitaria Parc Tauli
Sandra Montmany-Vioque, MD, PhD study director
Corporacion Sanitaria Parc Tauli
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 and Hypovolemic Shock, run by Andrea Campos-Serra at 1 site in Spain.
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 14 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 14 May 2019. 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 Spain. 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?
Mortality (time frame: Through study completion, an average of 1-2 years). 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 NCT02772653, 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 14 May 2019.