HemorrhagePhase 4NCT00337766
Desmopressin in Cardiac Surgery
A Phase 4 study testing Desmopressin (DDAVP) in people with Hemorrhage and Blood Loss, Surgical, run by Università Vita-Salute San Raffaele at 4 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hemorrhage, Blood Loss, Surgical, Postoperative Hemorrhage
- What is being tested?
- Desmopressin (DDAVP)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 4 sitesItaly
- Study dates
- Jun 2006to Sep 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing cardiac surgery
- excessive bleeding
Who cannot join
- age<18 y
- not signing written consent
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Istituto Ospedaliero Fondazione Poliambulanza
Brescia
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia
Milan, 20132
Istituto Policlinico S.Donato
Milan
Azienda Ospedaliera Universitaria Pisana
Pisa
About this study
Official title: Efficacy of Desmopressin (1-deamin0-8-D-arginine-vasopressin) in Reducing Active Microvascular Bleeding After Cardiac Surgery
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.
- Conditions
- Hemorrhage, Blood Loss, Surgical, Postoperative Hemorrhage
- Being tested
- Desmopressin (DDAVP), Placebo
- Keywords
- Blood Loss, Postoperative Blood loss
- Medical subject headings
- Hemorrhage, Blood Loss, Surgical, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desmopressin (DDAVP)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin (DDAVP) | Active comparator | Not described Receives: Drug: Desmopressin (DDAVP) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce transfusions
Secondary outcomes (4)
Reduced bleeding
Reduce time on mechanical ventilation
Reduced ICU and Hospital stay
Reduced mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionSep 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Investigators
- Giovanni Landoni, MD, Study director, Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia.Giuseppe Crescenzi, MD, Principal investigator, Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337766
- Sponsor's protocol ID
- DS/URC/ER/mm 151/DG
- Status last verified
- May 2013
- First submitted
- 15 Jun 2006
- Last updated
- 21 Oct 2015
- Results posted
- No
Publications
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.
PubMed 19034103
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Desmopressin (1-deamin0-8-D-arginine-vasopressin) in Reducing Active Microvascular Bleeding After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00337766
- Acronym / sponsor ID
- DS/URC/ER/mm 151/DG
- Conditions
- Hemorrhage, Blood Loss, Surgical, Postoperative Hemorrhage
- Keywords
- Blood Loss, Postoperative Blood loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 16 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desmopressin (DDAVP) | Active comparator | Drug: Desmopressin (DDAVP) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- undergoing cardiac surgery
- excessive bleeding
Key exclusion criteria (2 listed)
- age<18 y
- not signing written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desmopressin (DDAVP) | Drug | Desmopressin (DDAVP) |
| Placebo | Drug | Placebo |
Primary outcome
Reduce transfusions
4 secondary outcomes
Reduced bleeding
Reduce time on mechanical ventilation
Reduced ICU and Hospital stay
Reduced mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
- Background: PubMed 19034103Crescenzi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Landoni, MD study director
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia.
Giuseppe Crescenzi, MD principal investigator
Università Vita-Salute San Raffaele, Milano, Italia e Istituto Scientifico San Raffaele, Milano, Italia.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desmopressin (DDAVP) in people with Hemorrhage and Blood Loss, Surgical, run by Università Vita-Salute San Raffaele at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduce transfusions. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00337766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015; AzTrials last refreshed its copy on 31 Oct 2026.