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

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ClinicalTrials.gov Identifier: NCT01841515
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : May 13, 2013
Sponsor:
Information provided by (Responsible Party):
Soon Bae Kim, M.D., PhD., University of Ulsan

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.

Condition or disease Intervention/treatment Phase
Bleeding Tachycardia Dyspnea Drug: Desmopressin administration Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Desmopressin on Platelet Function in CKD Patients on Antiplatelet Agent Who Need Emergent Temporary Catheter Insertion for Hemodialysis
Study Start Date : August 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Bleeding after procedure [ Time Frame: 1-4 hr after procedure ]
    we observe incidence of bleeding complication after procedure



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841515


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Songpa-gu, Korea, Republic of, 138-736
Sponsors and Collaborators
University of Ulsan

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Responsible Party: Soon Bae Kim, M.D., PhD., Professor of Medicine, University of Ulsan
ClinicalTrials.gov Identifier: NCT01841515     History of Changes
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Dyspnea
Tachycardia
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Deamino Arginine Vasopressin
Platelet Aggregation Inhibitors
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs