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Table 1 Template of recommended content for the schedule of enrolment, interventions and assessments

From: Protocol for TRAUMADORNASE: a prospective, randomized, multicentre, double-blinded, placebo-controlled clinical trial of aerosolized dornase alfa to reduce the incidence of moderate-to-severe hypoxaemia in ventilated trauma patients

 

Visit

    

Information

Enrolment

Allocation, visit 0

Post-allocation, visits 1–7

Close-out

Timepoint

Day 0

Day 0

Day 0

Days 1–7

Day 30

Location

Hospital

Hospital

Hospital

Hospital

Hospital

Next of kin information

X*

X*

X

  

Signed informed consent

 

X*

   

Plasma βHCG assay

 

X(*)

   

Eligibility criteria check

X*

X*

X*

  

Randomization

  

X*

  

Study drug administration

  

X*d

X*d

 

Clinical examinationa

 

X

X

X

 

Diagnostic testsb

 

X

X

X

 

Blood assayc

  

X*

X*

 

Adverse effect recording

 

X*

X*

X*

X*

Concomitant medications

 

X

X

X

X

  1. βHCG beta human chorionic gonadotropin, X diagnostic test performed on a daily basis according to the standard of care in participating centres, X* diagnostic tests performed for the purpose of the TRAUMADORNASE study
  2. aClinical examination includes physical examination (auscultation of the chest, central body temperature, positive end-expiratory pressure and inspired oxygen fraction levels) and recording of Utstein criteria [49]
  3. bDiagnostic tests include arterial blood gases, chest X-ray, leukocyte and platelet counts, creatinine, blood urea nitrogen, bilirubin and quantitative lung bacteriologic samplings (bronchoalveolar lavage fluid or protected specimen brush) in the case of suspected lung infection
  4. cBlood withdrawal: 6 ml of blood on day 0, day 3 and day 5
  5. dStudy treatment will be given on day 0 and day 1
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