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

NCT01841515 | Completed Phase 1 DMC

• 1 other identifier: NCT00134031
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Bleeding; Tachycardia; Dyspnea

Outcome Measures

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.

  1 hour

Secondary Outcomes (1)

• Bleeding after procedure

  1-4 hr after procedure

Study Arms (1)

Desmopressin

EXPERIMENTAL

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

Desmopressin administration DRUG

Desmopressin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Ulsan: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

Location

MeSH Terms

Conditions

Hemorrhage; Tachycardia; Dyspnea

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: April 26, 2013
• Study Start: August 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 13, 2013

Record last verified: 2013-05

Locations

KR (1)