Prevention of Bleeding in Patient With Cirrhosis Undergoing Dental Extraction

What Was Tested

This registered not phased trial tested Desmopressin.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

DDAVP.

Standard Treatment.

The registry classes the interventions as biological and drug.

More on the Plan

The treatment approach to offset these abnormalities may involve transfusion with fresh frozen plasma (FFP) and platelets.

Furthermore, repeated platelet transfusion induces alloimmunization and refractoriness to new transfusion, which is an important issue in patients on the waiting list for liver transplantation in which HLA-matched and cross-matched platelets may be required.

Who Took Part

Enrollment: 36 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult patients with biopsy-proven liver cirrhosis or clinical/radiological evidence of cirrhosis, requiring dental extraction. Platelet count of 30,000-50,000/microL and/or INR 2.0-3.0.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: the presence of other bleeding disorders besides cirrhosis such as renal dysfunction (creatinine \> 2.0) or hiv; receipt of blood transfusion within 2 weeks prior to study; recent acute decompensation of liver cirrhosis.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Nothing was hidden in this open-label Desmopressin study: the participants and staff both knew the treatment.

It started in 2003-10 with completion listed for 2007-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Necessity of rescue blood transfusion in patients who received DDAVP or blood transfusion prior to dental extraction (time frame: 48 hours).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Desmopressin in 36 people.

Its size is small, so on its own it can only give an early look.

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.