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Effect of Desmopressin on Platelet Function in CKD Patients on Antiplatelet Drug
Plain-language guide to NCT01841515: phase 1 non-randomized trial of Desmopressin, 25 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01841515
- Phase
- phase 1
- Status
- completed
- Start
- 2012-08
- Completion (planned or actual)
- 2013-04
- Participants
- 25 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Bleeding; Tachycardia; Dyspnea
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Desmopressin.
Prolonged Collagen/Epinephrine - closure time (CEPI-CT) indicates platelet dysfunction in CKD patients taking antiplatelet agent.
Desmopressin also antagonizes the in vitro platelet dysfunction induced by GPIIb/IIIa inhibitors, clopidogrel and aspirin.
It had 1 arm (groups): Desmopressin (experimental).
Twenty five patients with chronic kidney disease and who were taking antiplatelet agents and needed an emergent catheter insertion for hemodialysis.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 25 actual participants took part.
It was open to people of any sex aged from 20 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Adult uremic patients with one or more antiplatelet medication,. Prolonged collagen/epinephrine (CEPI) closure time,. Need for emergent hemodialysis and. Subsequent catheter insertion.
The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: acute coronary syndrome,; hemophilia, and nephrogenic diabetes insipidus,; allergy against desmopressin.
How the Study Was Run
It was run as a non-randomized, single-group and open-label study.
Everyone knew when Desmopressin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2012-08 with completion listed for 2013-04.
It ran at 1 site in South Korea.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): collagen-epinephrine closure time (time frame: 1 hour).
It also tracked 1 secondary outcome, for example Bleeding after procedure.
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Desmopressin in 25 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.
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.