HEPBURN - investigating the efficacy and safety of nebulized heparin versus placebo in burn patients with inhalation trauma: study protocol for a multi-center randomized controlled trial

Table 2 Time schedule of study procedures

	Day of admission (day 1)	Every day^b/c	Days 1, 3, 5, 7, 9, 11 and 13^c	Day of hospital discharge	Day 28	Day 90
Screening and randomization
screening^a	X
demographic data	X
inclusion criteria	X
exclusion criteria	X
informed consent	X
randomization	X
Before start study medication
blood sampling	X
non directed broncho-alveolar lavage sampling	X
Clinical procedures
chest X-ray		X
nebulization of study medication^c,d		X
blood sampling^c			X
non-directed broncho-alveolar lavage sampling^c			X
Clinical data collection
%TBSA	X
SAPS II	X
Karnofsky score	X
ABSI	X
SOFA score		X
LIS/OI		X
ventilatory settings		X
relevant medications^e		X
sedation		X
fluid balance		X
Other data collection
adverse event		X
use of blood products		X
use of protamine		X
use of n-acetylcysteine		X
use of vasopressors^f		X
bronchoscopy^g		X
pneumonia (VAP)		X
date of hospital discharge				X
Survival, if not:				X	X	X
date of death				X	X	X
cause of death

^aOf all patients with suspected inhalation injury.
^bFor the maximum duration of 28 days.
^cFor the maximum duration of 14 days or until the patient is successfully weaned from mechanical ventilation.
^dIf temporarily or definitely discontinued, reason should be registered.
^eSuch as antibiotics, immunosuppressives, systemic anticoagulants.
^fSuch as dopamine, dobutamine, norepinephrine, or epinephrine.
^gTo remove foreign particles and accumulated secretions.

ISSN: 1745-6215