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DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty
Plain-language guide to NCT01982760: phase 2 randomized trial of Desmopressin, 14 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01982760
- Phase
- phase 2
- Status
- terminated early
- Start
- 2013-12
- Completion (planned or actual)
- 2015-06-25
- Participants
- 14 (actual)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Postoperative Ecchymosis
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Desmopressin.
DDAVP is a drug used in patients with bleeding disorders.
It works by activating molecules in the blood stream called platelets that promote clotting.
It had two arms (groups): DDAVP (experimental) and No DDAVP (no intervention).
Patients Will not receive DDAVP prior to Rhinoplasty.
The registry classes the interventions as drug.
Who Took Part
14 actual participants took part.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Undergoing Rhinoplasty where nasal bone osteotomy is necessary.
The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: heart disease; liver disease.
How the Study Was Run
The set-up was randomized, parallel-group and triple-blind.
The participants were allocated by chance, so the Desmopressin group and the comparison group should start out alike.
The Desmopressin group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on Desmopressin, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, investigator and outcomes assessor.
It started in 2013-12 with completion listed for 2015-06-25.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 1 secondary outcome, for example Patient Behavior Factors.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Desmopressin in 14 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); results are posted on the registry, and this page does not restate them.
More context: the Desmopressin compound page, all human trials.
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.