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

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

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 Overview

• Status: Completed
• Conditions: Bleeding; Tachycardia; Dyspnea
• Intervention / Treatment: Drug: Desmopressin administration

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding after procedure	we observe incidence of bleeding complication after procedure	1-4 hr after procedure

Collaborators and Investigators

• Sponsor: University of Ulsan

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: April 23, 2013
• First Submitted That Met QC Criteria: April 25, 2013
• First Posted (Estimate): April 26, 2013

Study Record Updates

• Last Update Posted (Estimate): May 13, 2013
• Last Update Submitted That Met QC Criteria: May 9, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Dyspnea; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Antidiuretic Agents; Deamino Arginine Vasopressin
• Other Study ID Numbers: NCT00134031