NCT02772653

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2019

Completed
Last Updated

May 14, 2019

Status Verified

May 1, 2019

Enrollment Period

2.9 years

First QC Date

May 7, 2016

Last Update Submit

May 11, 2019

Conditions

TraumaHypovolemic Shock

Keywords

MicrocirculationVideomicroscopySpectroscopy, Near-InfraredB-Type Natriuretic PeptideThromboelastometryTraumaResuscitationHypovolemic shock

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Death of the patient

    Through study completion, an average of 1-2 years

Secondary Outcomes (5)

  • Multiple organ dysfunction (Multiple Organ Dysfunction Score)

    Through study completion, an average of 1-2 years

  • Blood cell transfusion

    Through study completion, an average of 1-2 years

  • Activation of the Massive blood transfusion protocol

    At hospital admission

  • Surgical intervention for bleeding control

    Through study completion, an average of 1-2 years

  • Arteriographic embolization for bleeding control

    Through study completion, an average of 1-2 years

Other Outcomes (2)

  • Hospital stay

    Through study completion, an average of 1-2 years

  • Intensive care unit stay

    Through study completion, an average of 1-2 years

Study Arms (1)

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.

Other: Blood LactateOther: Blood Base ExcessOther: Blood B-type Natriuretic PeptideOther: Blood Thromboelastometry (ROTEM)Other: Near-infrared spectroscopyOther: Sublingual videomicroscopy

Interventions

Blood LactateOTHER

Analyzed at the 1rst, 8th and 24th hour from hospital admission

Severe trauma patients
Blood Base ExcessOTHER

Analyzed at the 1rst, 8th and 24th hour from hospital admission

Severe trauma patients
Blood B-type Natriuretic PeptideOTHER

Analyzed at the 1rst, 8th and 24th hour from hospital admission

Severe trauma patients
Blood Thromboelastometry (ROTEM)OTHER

Analyzed at the 1rst, 8th and 24th hour from hospital admission

Severe trauma patients
Near-infrared spectroscopyOTHER

Analyzed at the 1rst, 8th and 24th hour from hospital admission

Severe trauma patients
Sublingual videomicroscopyOTHER

Analyzed at the 1rst, 8th and 24th hour from hospital admission

Severe trauma patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Severe trauma patients admitted at Corporacio Sanitaria Parc Tauli

You may qualify if:

  • 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:
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corporacion Sanitaria Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (1)

  • 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.

    PMID: 36053289DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for Natriuretic Peptide analysis. Retained just for one month, until samples are analyzed at an external laboratory.

MeSH Terms

Conditions

Wounds and InjuriesShock

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Andrea Campos-Serra, MD

    Corporacion Sanitaria Parc Tauli

    PRINCIPAL INVESTIGATOR

  • Salvador Navarro-Soto, MD, PhD

    Corporacion Sanitaria Parc Tauli

    STUDY DIRECTOR

  • Sandra Montmany-Vioque, MD, PhD

    Corporacion Sanitaria Parc Tauli

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 7, 2016

First Posted

May 13, 2016

Study Start

May 1, 2016

Primary Completion

March 26, 2019

Study Completion

March 26, 2019

Last Updated

May 14, 2019

Record last verified: 2019-05

Locations

ES(1)