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EFFICACY OF DESMOPRESSINA IN PATIENT WITH ACTIVE BLEEDING AFTER HEART SURGERY. - ND

EFFICACY OF DESMOPRESSINA IN PATIENT WITH ACTIVE BLEEDING AFTER HEART SURGERY. - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005199-33-IT
Enrollment
108
Registered
2006-01-31
Start date
2006-03-13
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIGH BLEEDING AFTER HEART SURGERY MedDRA version: 6.1 Level: HLGT Classification code 10007593

Interventions

Trade Name: EMOSINT INIETT.10F 20 MCG/ML Pharmaceutical Form: Solution for infusion INN or Proposed INN: Desmopressin CAS Number: 62357-86-2 Concentration unit: µg microgram(s) Concentration type: equ

Sponsors

OSPEDALE S. RAFFAELE
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026