HIGH BLEEDING AFTER HEART SURGERY MedDRA version: 6.1 Level: HLGT Classification code 10007593
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -HEART SURGERY; -HOSPEDALIZATION IN INTENSIVE CARE UNIT WITH HIGH BLEEDING FOR ABOUT 1 HOUR BLEEDING 100 ML IN THE LAST 30 MINUTES OR PATINTS WITH HIGH BLEEDING 2ML/kG/MIN FOR AT LEAST 2 HOURS Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -PATIENTS WITH AGE LOWER THAN 18; -LACK OF INFORMED CONSENT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: EVALUATION OF DESMOPRESSINA USE VS PLACEBO IN BLOOD TRANSFUSIONS REDUCTION IN PATIENTS WITH HIGH POSTOPERATIVE BLEEDING.;Secondary Objective: PLEASE SEE PRIMARY OBJECTIVE;Primary end point(s): share of patients that have bloodtransfusion during hospitalization in heartsurgery intensive care after desmopressina vs placebo administration. | — |
Countries
Italy