Back to resultsEffect of Desmopressin on Platelet Function in CKD Patients on Antiplatelet Drug
Primary Purpose
Bleeding, Tachycardia, Dyspnea
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Desmopressin administration
Sponsored by
About this trial
This is an interventional treatment trial for Bleeding
Eligibility 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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Desmopressin
Arm Description
Twenty five patients with chronic kidney disease and who were taking antiplatelet agents and needed an emergent catheter insertion for hemodialysis
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Bleeding after procedure
we observe incidence of bleeding complication after procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01841515
Brief Title
Effect of Desmopressin on Platelet Function in CKD Patients on Antiplatelet Drug
Official Title
Effect of Desmopressin on Platelet Function in CKD Patients on Antiplatelet Agent Who Need Emergent Temporary Catheter Insertion for Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulsan
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding, Tachycardia, Dyspnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Desmopressin
Arm Type
Experimental
Arm Description
Twenty five patients with chronic kidney disease and who were taking antiplatelet agents and needed an emergent catheter insertion for hemodialysis
Intervention Type
Drug
Intervention Name(s)
Desmopressin administration
Primary Outcome Measure Information:
Title
collagen-epinephrine closure time
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Bleeding after procedure
Description
we observe incidence of bleeding complication after procedure
Time Frame
1-4 hr after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Desmopressin on Platelet Function in CKD Patients on Antiplatelet Drug
We'll reach out to this number within 24 hrs