Trial Outcomes & Findings for Independent Predictors of Mortality in Polytrauma Patients (NCT NCT01669577)

Results Overview

30 days after trauma mortality evaluation

Recruitment status

COMPLETED

Target enrollment

200 participants

Primary outcome timeframe

Within the first 30 days

Results posted on

2015-01-09

Participant Flow

334 patients were collected during São Paulo rescue system activities. Entry criteria was defined as hypotensive patients (SBP\<90mmHg at the scene, high-energy traumas, severe TBI); patients under 18 years old were excluded. If calculated ISS \< 16 or no informed consent, patients were excluded.

Pre assignment were not performed, as patients were not known.

Participant milestones

Participant milestones
Measure	Severe Trauma Patients intervention : analysis of blood samples analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml) analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR collection of vital signs, blood chemistry; severity scores and intensive care unit(ICU) LOS(length of stay) were recorded
Overall Study STARTED	334
Overall Study COMPLETED	200
Overall Study NOT COMPLETED	134

Reasons for withdrawal

Reasons for withdrawal
Measure	Severe Trauma Patients intervention : analysis of blood samples analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml) analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR collection of vital signs, blood chemistry; severity scores and intensive care unit(ICU) LOS(length of stay) were recorded
Overall Study Death	22
Overall Study Lost to Follow-up	78
Overall Study Physician Decision	34

Baseline Characteristics

Independent Predictors of Mortality in Polytrauma Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Severe Trauma Patients n=200 Participants Hypotensive Patients (SBP\<90mmHg), severe TBI, high energy traumas All patients must have calculated ISS \>15 to be included and a written informed consent should be available
Age, Continuous Continuous	37 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	164 Participants n=5 Participants
Region of Enrollment Brazil	200 participants n=5 Participants

PRIMARY outcome

Timeframe: Within the first 30 days

Population: severe polytrauma patients (ISS\>15)

30 days after trauma mortality evaluation

Outcome measures

Outcome measures
Measure	Severe Trauma Patients n=200 Participants intervention : analysis of blood samples; vital signs and clinical outcomes recorded analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml) analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR
Death	52 participants

Adverse Events

Severe Trauma Patients

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Severe Trauma Patients n=200 participants at risk intervention : analysis of blood samples analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml) analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR
Vascular disorders Thrombophlebitis	0.50% 1/200 • Number of events 1 • 30 days follow up Patients were monitored for adverse outcomes related to venipuncture, as this was the unique intervention.

Other adverse events

Other adverse events
Measure	Severe Trauma Patients n=200 participants at risk intervention : analysis of blood samples analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml) analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR
Infections and infestations Infection	1.0% 2/200 • Number of events 2 • 30 days follow up Patients were monitored for adverse outcomes related to venipuncture, as this was the unique intervention.

Additional Information

Luiz Guilherme Villares da Costa, MD

University of São Paulo

Phone: 5511985584737

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place