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

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841515
• Other study ID #: NCT00134031
• Status: Completed
• Phase: Phase 1
• First received: April 23, 2013
• Last updated: May 9, 2013
• Start date: August 2012
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: University of Ulsan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bleeding
• Dyspnea
• Tachycardia

Intervention

Drug:
• Desmopressin administration

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulsan

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Bleeding after procedure	we observe incidence of bleeding complication after procedure	1-4 hr after procedure	No