Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
66 participants
OBSERVATIONAL
2016-05-31
2019-03-26
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
Blood Lactate
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Blood Base Excess
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Blood B-type Natriuretic Peptide
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Blood Thromboelastometry (ROTEM)
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Near-infrared spectroscopy
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Sublingual videomicroscopy
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Interventions
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Blood Lactate
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Blood Base Excess
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Blood B-type Natriuretic Peptide
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Blood Thromboelastometry (ROTEM)
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Near-infrared spectroscopy
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Sublingual videomicroscopy
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Eligibility Criteria
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Inclusion Criteria
* 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:
* 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
Exclusion Criteria
* Patients transported from an other hospital (first hours of medical support done elsewhere)
18 Years
ALL
No
Sponsors
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Corporacion Parc Tauli
OTHER
Andrea Campos-Serra
OTHER
Responsible Party
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Andrea Campos-Serra
MD
Principal Investigators
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Andrea Campos-Serra, MD
Role: PRINCIPAL_INVESTIGATOR
Corporacion Sanitaria Parc Tauli
Salvador Navarro-Soto, MD, PhD
Role: STUDY_DIRECTOR
Corporacion Sanitaria Parc Tauli
Sandra Montmany-Vioque, MD, PhD
Role: STUDY_DIRECTOR
Corporacion Sanitaria Parc Tauli
Locations
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Corporacion Sanitaria Parc Tauli
Sabadell, Barcelona, Spain
Countries
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References
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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.
Other Identifiers
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CSPT-CG-PPT1
Identifier Type: -
Identifier Source: org_study_id
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