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

• Sponsor: University of Ulsan (Other)
• Overall Status: Completed
• CT.gov ID: NCT01841515
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arm: 1
• Duration (Months): 8
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Aug 1, 2012
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. collagen-epinephrine closure time [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 [1-4 hr after procedure]

   we observe incidence of bleeding complication after procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asan Medical Center	Seoul	Songpa-gu	Korea, Republic of	138-736

Sponsors and Collaborators

• University of Ulsan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Soon Bae Kim, M.D., PhD., Professor of Medicine, University of Ulsan
• ClinicalTrials.gov Identifier: NCT01841515
• Other Study ID Numbers: NCT00134031
• First Posted: Apr 26, 2013
• Last Update Posted: May 13, 2013
• Last Verified: May 1, 2013

• Additional relevant MeSH terms: Dyspnea; Tachycardia; Deamino Arginine Vasopressin

Study Results

No Results Posted as of May 13, 2013