Study of DDAVP Combined With TXA on the Blood Loss and Transfusion Need During and After Scoliosis Correction Surgery

What Was Tested

In this not phased trial, researchers set out to test Desmopressin.

TXA acts mainly by inhibit the plasminogen activator.

Desmopressin (DDAVP ,D) can inhibit the fibrinolytic activity by inducing the release of von Willebrand factor from the endothelial cells.

It had two arms (groups): Group TN (placebo comparator) and Group TD (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 8 years up to 18 years.

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

Examples of who could join: Idiopathic scoliosis patients undergoing posterior scoliosis correction surgery. American society of anesthesiologists(ASA) classification:Ⅰ-Ⅱ. Patients who agreed to participate in this study and has signed the informed consent.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: blood disease，such as anaemia, idiopathic thrombocytopenic purpura(itp); history of bleeding or ecchymosis; disorders of laboratory examination on platelets(plt),prothrombin time(pt),activated partial thromboplastin time(aptt),fibrinogen,d-dimers.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind 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.

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, care provider, investigator and outcomes assessor.

It started in 2013-12 with completion listed for 2014-04.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: blood loss (time frame: during and 3 days after the surgery).

It also tracked 1 secondary outcome, for example blood transfusion.

What This Means in Plain Language

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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