← Human Trials & Peer-Reviewed Studies

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.