Effect of Aspirin, Hemodilution and Desmopressin on Platelet Dysfunction

What Was Tested

This registered not phased trial tested Desmopressin.

Although this hypothermia-induced platelet dysfunction seems to be reversible with warming, this is not always possible or desirable.

It had two arms (groups): Placebo group (placebo comparator) and Aspirin group (active comparator).

The registry classes the interventions as drug.

More on the Plan

Mild hypothermia (34-35oC) is known to cause platelet dysfunction.

This degree of hypothermia is common during any general anaesthesia, particularly during surgeries which invlove major fluid shift and large area exposure of patients, e.g. trauma and burn patients.

Although this hypothermia-induced platelet dysfunction seems to be reversible with warming, warming is not always possible or desirable.

During major trauma or burn surgery, surface warming of patient is practically difficult.

Who Took Part

The registry lists 60 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 60 adult Chinese subjects aged 18-60 without known platelet disorder, thrombocytopenia, history of taking drugs that may affect platelet function including herbal preparations.

The full record lists 1 inclusion and 11 exclusion criteria; among the exclusions: any known platelet or coagulation disorder; expected surgical operation or dental treatment within one week of scheduled drug intake; known peptic ulcer 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.

Blinding on both sides kept the participants and researchers unaware of who received Desmopressin.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2011-07 with completion listed for 2012-07.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Platelet function (time frame: Day 6 after aspirin intake).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Desmopressin in 60 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Desmopressin compound page, all human trials.