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Evaluation of Resuscitation Markers in Trauma Patients

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ClinicalTrials.gov Identifier: NCT02772653
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
Corporacion Parc Tauli
Information provided by (Responsible Party):
Andrea Campos-Serra, Corporacion Parc Tauli

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.


Condition or disease Intervention/treatment
Trauma Hypovolemic Shock Other: Blood Lactate Other: Blood Base Excess Other: Blood B-type Natriuretic Peptide Other: Blood Thromboelastometry (ROTEM) Other: Near-infrared spectroscopy Other: Sublingual videomicroscopy

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Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of Resuscitation Markers in Trauma Patients
Study Start Date : May 2016
Actual Primary Completion Date : March 26, 2019
Actual Study Completion Date : March 26, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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 Lactate
Analyzed at the 1rst, 8th and 24th hour from hospital admission

Other: Blood Base Excess
Analyzed at the 1rst, 8th and 24th hour from hospital admission

Other: Blood B-type Natriuretic Peptide
Analyzed at the 1rst, 8th and 24th hour from hospital admission

Other: Blood Thromboelastometry (ROTEM)
Analyzed at the 1rst, 8th and 24th hour from hospital admission

Other: Near-infrared spectroscopy
Analyzed at the 1rst, 8th and 24th hour from hospital admission

Other: Sublingual videomicroscopy
Analyzed at the 1rst, 8th and 24th hour from hospital admission




Primary Outcome Measures :
  1. Mortality [ Time Frame: Through study completion, an average of 1-2 years ]
    Death of the patient


Secondary Outcome Measures :
  1. Multiple organ dysfunction (Multiple Organ Dysfunction Score) [ Time Frame: Through study completion, an average of 1-2 years ]
    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.

  2. Blood cell transfusion [ Time Frame: Through study completion, an average of 1-2 years ]
    Need for blood cell transfusion for patients

  3. Activation of the Massive blood transfusion protocol [ Time Frame: At hospital admission ]
    Need for massive transfusion protocol activation on patients with suspicion of active bleeding

  4. Surgical intervention for bleeding control [ Time Frame: Through study completion, an average of 1-2 years ]
    Need for surgical control on patients with active bleeding

  5. Arteriographic embolization for bleeding control [ Time Frame: Through study completion, an average of 1-2 years ]
    Need for arteriographic embolization on patients with active bleeding


Other Outcome Measures:
  1. Hospital stay [ Time Frame: Through study completion, an average of 1-2 years ]
    Number of days that the patient remains in hospital

  2. Intensive care unit stay [ Time Frame: Through study completion, an average of 1-2 years ]
    Number of days that the patient remains in the intensive care unit


Biospecimen Retention:   Samples Without DNA
Blood samples for Natriuretic Peptide analysis. Retained just for one month, until samples are analyzed at an external laboratory.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Severe trauma patients admitted at Corporacio Sanitaria Parc Tauli
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772653


Locations
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Spain
Corporacion Sanitaria Parc Tauli
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Andrea Campos-Serra
Corporacion Parc Tauli
Investigators
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Principal Investigator: Andrea Campos-Serra, MD Corporacion Sanitaria Parc Tauli
Study Director: Salvador Navarro-Soto, MD, PhD Corporacion Sanitaria Parc Tauli
Study Director: Sandra Montmany-Vioque, MD, PhD Corporacion Sanitaria Parc Tauli
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Responsible Party: Andrea Campos-Serra, MD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT02772653    
Other Study ID Numbers: CSPT-CG-PPT1
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Keywords provided by Andrea Campos-Serra, Corporacion Parc Tauli:
Microcirculation
Videomicroscopy
Spectroscopy, Near-Infrared
B-Type Natriuretic Peptide
Thromboelastometry
Trauma
Resuscitation
Hypovolemic shock
Additional relevant MeSH terms:
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Shock
Hypovolemia
Wounds and Injuries
Pathologic Processes
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs