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Completed

NCT Number: NCT02772653

Evaluation of Resuscitation Markers in Trauma Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Corporacion Sanitaria Parc Tauli

Sabadell, Barcelona, 08208, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood Lactate

Other

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

Blood Base Excess

Other

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

Blood B-type Natriuretic Peptide

Other

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 spectroscopy

Other

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

Sublingual videomicroscopy

Other

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

Primary outcomes

  1. Mortality

    Time frame: Through study completion, an average of 1-2 years

    Death of the patient

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Andrea Campos-Serra

Other

Collaborators

  • Corporacion Parc Tauli

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 13, 2016
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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