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Clinical Trials/NCT01841515
NCT01841515
Completed
Phase 1

Effect of Desmopressin on Platelet Function in CKD Patients on Antiplatelet Agent Who Need Emergent Temporary Catheter Insertion for Hemodialysis

University of Ulsan1 site in 1 country25 target enrollmentStarted: August 2012Last updated:

Overview

Phase
Phase 1
Status
Completed
Enrollment
25
Locations
1
Primary Endpoint
collagen-epinephrine closure time

Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
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

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

Arms & Interventions

Desmopressin

Experimental

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

Intervention: Desmopressin administration (Drug)

Outcomes

Primary Outcomes

collagen-epinephrine closure time

Time Frame: 1 hour

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.

Secondary Outcomes

  • Bleeding after procedure(1-4 hr after procedure)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Soon Bae Kim, M.D., PhD.

Professor of Medicine

University of Ulsan

Study Sites (1)

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