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Desmopressin in Cardiac Surgery
Plain-language guide to NCT00337766: phase 4 randomized trial of Desmopressin, post-surgical inflammation and surgery recovery. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00337766
- Phase
- phase 4
- Status
- completed
- Start
- 2006-06
- Completion (planned or actual)
- 2009-09
- Participants
- n/a
- Design
- randomized, quadruple-blind, prevention
- Conditions studied
- Hemorrhage; Blood Loss, Surgical; Postoperative Hemorrhage
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Desmopressin for post-surgical inflammation and surgery recovery.
Patients undergoing cardiac surgery could develop excessive perioperative bleeding requiring transfusions of blood products.
It had two arms (groups): Desmopressin (DDAVP) (active comparator) and Placebo (placebo comparator).
The registry classes the interventions as drug.
Who Took Part
It was open to people of any sex aged from 18 years up to 100 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Undergoing cardiac surgery.
The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: age\<18 y; not signing written consent.
How the Study Was Run
The set-up was randomized, parallel-group and quadruple-blind.
Because people in this Desmopressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Desmopressin group and the comparison group ran side by side rather than switching.
Blinding on both sides kept the post-surgical inflammation and surgery recovery participants and researchers unaware of who received Desmopressin.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2006-06 with completion listed for 2009-09.
It ran at 4 sites in Italy (4).
Its stated primary purpose is prevention.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Desmopressin in people with post-surgical inflammation and surgery recovery.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Desmopressin compound page, Post-surgical inflammation and surgery recovery research.
Our Notes on the Compound
Desmopressin: A synthetic vasopressin analog (DDAVP) used for bedwetting, diabetes insipidus and some bleeding disorders.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.