Evaluation of Resuscitation Markers in Trauma Patients

Completed

• Conditions: Hypovolemic Shock; Trauma
• Interventions: Other: Blood Lactate; Other: Blood Base Excess; Other: Blood B-type Natriuretic Peptide; Other: Blood Thromboelastometry (ROTEM); Other: Near-infrared spectroscopy; Other: Sublingual videomicroscopy

• Registration Number: NCT02772653
• Lead Sponsor: Andrea Campos-Serra

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-07
• Study First Submitted QC: 2016-05-12
• Study First Posted: 2016-05-13
• Primary Completion: 2019-03-26
• Study Completion: 2019-03-26
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-11
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe trauma patients	Blood Lactate	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.
Severe trauma patients	Blood Base Excess	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.
Severe trauma patients	Blood Thromboelastometry (ROTEM)	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.
Severe trauma patients	Sublingual videomicroscopy	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.
Severe trauma patients	Blood B-type Natriuretic Peptide	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.
Severe trauma patients	Near-infrared spectroscopy	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.

Primary Outcome Measures

Name	Time	Method
Mortality	Through study completion, an average of 1-2 years	Death of the patient

Secondary Outcome Measures

Name	Time	Method
Blood cell transfusion	Through study completion, an average of 1-2 years	Need for blood cell transfusion for patients
Multiple organ dysfunction (Multiple Organ Dysfunction Score)	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.
Activation of the Massive blood transfusion protocol	At hospital admission	Need for massive transfusion protocol activation on patients with suspicion of active bleeding
Arteriographic embolization for bleeding control	Through study completion, an average of 1-2 years	Need for arteriographic embolization on patients with active bleeding
Surgical intervention for bleeding control	Through study completion, an average of 1-2 years	Need for surgical control on patients with active bleeding

Trial Locations

Locations (1)

Corporacion Sanitaria Parc Tauli; 🇪🇸 Sabadell, Barcelona, Spain