Desmopressin in Cardiac Surgery

NCT ID: NCT00337766

Last Updated: 2015-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hemorrhage Blood Loss, Surgical Postoperative Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Desmopressin (DDAVP)

Group Type ACTIVE_COMPARATOR

Desmopressin (DDAVP)

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Desmopressin (DDAVP)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* undergoing cardiac surgery
* excessive bleeding

Exclusion Criteria

* age\<18 y
* not signing written consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università Vita-Salute San Raffaele

OTHER

Sponsor Role lead

Principal Investigators

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Giovanni Landoni, MD

Role: STUDY_DIRECTOR

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

Giuseppe Crescenzi, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Istituto Ospedaliero Fondazione Poliambulanza

Brescia, , Italy

Site Status

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

Milan, , Italy

Site Status

Istituto Policlinico S.Donato

Milan, , Italy

Site Status

Azienda Ospedaliera Universitaria Pisana

Pisa, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 19034103 (View on PubMed)

Other Identifiers

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DS/URC/ER/mm 151/DG

Identifier Type: -

Identifier Source: org_study_id

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