NCT00337766

Brief Summary

Patients undergoing cardiac surgery could develop excessive perioperative bleeding requiring transfusions of blood products. Desmopressin (DDAVP), already used for patients with von Willebrand syndrome, could reduce bleeding and transfusion requirements in these patients when administered ev (0.3 mg/kg) in 20-30 minutes postoperatively.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

October 21, 2015

Status Verified

May 1, 2013

Enrollment Period

3.3 years

First QC Date

June 15, 2006

Last Update Submit

October 20, 2015

Conditions

HemorrhageBlood Loss, SurgicalPostoperative Hemorrhage

Keywords

Blood LossPostoperative Blood loss

Outcome Measures

Primary Outcomes (1)

  • Reduce transfusions

Secondary Outcomes (4)

  • Reduced bleeding

  • Reduce time on mechanical ventilation

  • Reduced ICU and Hospital stay

  • Reduced mortality

Study Arms (2)

Desmopressin (DDAVP)

ACTIVE COMPARATOR
Drug: Desmopressin (DDAVP)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Desmopressin (DDAVP)DRUG
Desmopressin (DDAVP)
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergoing cardiac surgery
  • excessive bleeding

You may not qualify if:

  • age\<18 y
  • not signing written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Istituto Ospedaliero Fondazione Poliambulanza

Brescia, Italy

Location

Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia

Milan, 20132, Italy

Location

Istituto Policlinico S.Donato

Milan, Italy

Location

Azienda Ospedaliera Universitaria Pisana

Pisa, Italy

Location

Related Publications (1)

  • Crescenzi G, Landoni G, Biondi-Zoccai G, Pappalardo F, Nuzzi M, Bignami E, Fochi O, Maj G, Calabro MG, Ranucci M, Zangrillo A. Desmopressin reduces transfusion needs after surgery: a meta-analysis of randomized clinical trials. Anesthesiology. 2008 Dec;109(6):1063-76. doi: 10.1097/ALN.0b013e31818db18b.

    PMID: 19034103BACKGROUND

MeSH Terms

Conditions

HemorrhageBlood Loss, SurgicalPostoperative Hemorrhage

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative ComplicationsPostoperative Complications

Intervention Hierarchy (Ancestors)

Arginine VasopressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Giovanni Landoni, MD

    Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia.

    STUDY DIRECTOR

  • Giuseppe Crescenzi, MD

    Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2006

First Posted

June 16, 2006

Study Start

June 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2010

Last Updated

October 21, 2015

Record last verified: 2013-05

Locations

IT(4)