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CompletedNCT01841515Updated May 13, 2013

Effect of Desmopressin on Platelet Function in CKD Patients on Antiplatelet Drug

A Phase 1 interventional study of Desmopressin administration in Bleeding, Tachycardia and Dyspnea, sponsored by University of Ulsan. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-05-13.

Sponsored by University of Ulsan · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study summary

Prolonged Collagen/Epinephrine - closure time (CEPI-CT) indicates platelet dysfunction in CKD patients taking antiplatelet agent. The synthetic vasopressin derivative, Desmopressin (DDAVP) shortens the prolonged bleeding time and improves platelet dysfunction measured by in vitro closure time: CEPI-CT in uremic patients. Desmopressin also antagonizes the in vitro platelet dysfunction induced by GPIIb/IIIa inhibitors, clopidogrel and aspirin. The investigators designed a prospective study to evaluate the effect of desmopressin on platelet function, as measured by in vitro collagen/epinephrine - closure time, in uremic patients who were taking antiplatelet drugs.

02

Conditions studied

  • Bleeding
  • Tachycardia
  • Dyspnea
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • adult uremic patients with one or more antiplatelet medication,
  • prolonged collagen/epinephrine (CEPI) closure time,
  • need for emergent hemodialysis and
  • subsequent catheter insertion

Exclusion criteria

Exclusion Criteria:

  • acute coronary syndrome,
  • hemophilia, and nephrogenic diabetes insipidus,
  • allergy against desmopressin
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Desmopressin

    Twenty five patients with chronic kidney disease and who were taking antiplatelet agents and needed an emergent catheter insertion for hemodialysis

    Drug: Desmopressin administration

Interventions

  • DrugDesmopressin administration
05

What researchers measure

Primary outcomes

  1. collagen-epinephrine closure time

    In vitro closure time (CT), measured using a platelet function analyzer (PFA)-100, is a relatively new tool for investigation of primary hemostasis. This system has been shown to be efficacious in evaluating abnormalities of primary hemostasis.

    Time frame: 1 hour

Secondary outcomes

  1. Bleeding after procedure

    we observe incidence of bleeding complication after procedure

    Time frame: 1-4 hr after procedure

06

Study locations

1 site
  • Asan Medical Center
    Seoul, Songpa-gu 138-736, Korea, Republic of
07

Registry details

Key details

Study ID
NCT01841515
Lead sponsor
University of Ulsan
Responsible party
Soon Bae Kim, M.D., PhD. (Professor of Medicine, University of Ulsan) — Principal investigator
First posted
Apr 26, 2013
Start date
Aug 2012
Primary completion
Apr 2013
Completion
Apr 2013
Last update
May 13, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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