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Fibrinogen-to-Albumin Ratio as a Predictor of Acute Respiratory Distress Syndrome in Traumatic Brain Injury

ConditionsFibrinogenAlbuminARDSTBI (Traumatic Brain Injury)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTanta University

About this trial

this study aims to assess the ability of fibrinogen-to-albumin ratio to predict the development of Acute respiratory distress syndrome in traumatic brain injury patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients ≥ 18 years admitted to the ICU with traumatic Brain Injury

Admission to the ICU within 24 hours of injury.

Patients will be expected to remain under hospital care for follow-up

Availability of fibrinogen and albumin measurements within the first 24 hours of ICU admission.

Disqualifiers

Preexisting advanced chronic liver disease, nephrotic syndrome, or protein-losing enteropathy.

Pre-existing ARDS on admission.

Recipient of albumin, fibrinogen concentrate, or cryoprecipitate before admission sampling.

Use of anticoagulant or fibrinolytic therapy before admission.

Trial population

Patients aged ≥ 18 years admitted to the ICU within 24 hours of traumatic Brain Injury.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Fibrinogen-to-albumin ratio

    Diagnostic test

    Fibrinogen (g/L) and albumin (g/L) levels in the blood will be measured from the first routine blood sample after ICU admission. Fibrinogen-to-albumin ratio will be calculated as: FAR = Fibrinogen (g/L)/Albumin (g/L)

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Acute respiratory distress syndrome group1 intervention
Group B: Non acute respiratory distress syndrome group1 intervention

Trial outcomes

Primary outcomes

1

The accuracy of early fibrinogen-to-albumin ratio (within 24 hours of ICU admission) to predict the development of acute respiratory distress syndrome in traumatic brain injury patients.

Fibrinogen (g/L) and albumin (g/L) levels in the blood will be measured from the first routine blood sample after ICU admission. Fibrinogen-to-albumin ratio will be calculated as: FAR = Fibrinogen (g/L)/Albumin (g/L)

Time frame
up to 7 days after traumatic brain injury.

Secondary outcomes

1

Incidence of acute respiratory distress syndrome

Development of ARDS within 7 days of ICU admission, defined according to the Berlin criteria will be recorded.

Time frame
up to 7 days after traumatic brain injury.
2

Severity of acute respiratory distress syndrome.

It will be evaluated by the PaO2/FiO2 ratio. PaO2/FiO2 ratio between 200 and 300 will be considered mild ARDS. PaO2/FiO2 ratio between 200 and 100 will be considered moderate ARDS. PaO2/FiO2 ratio less than 100 will be considered severe ARDS.

Time frame
up to 7 days after traumatic brain injury.
3

Duration of mechanical ventilation

patients who will require mechanical ventilation for management of hypoxemia will be evaluated for the duration of mechanical ventilation.

Time frame
Up to 30 days after traumatic brain injury.
4

ICU length of stay and mortality rate

Death during ICU stay or thereafter will be recorded.

Time frame
Up to 90 days after traumatic brain injury.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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