BleedingPhase 1NCT01841515
Effect of Desmopressin on Platelet Function in CKD Patients on Antiplatelet Drug
A Phase 1 study testing Desmopressin administration in people with Bleeding and Tachycardia, run by University of Ulsan at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bleeding, Tachycardia, Dyspnea
- What is being tested?
- Desmopressin administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult uremic patients with one or more antiplatelet medication,
- prolonged collagen/epinephrine (CEPI) closure time,
- need for emergent hemodialysis and
- subsequent catheter insertion
Who cannot join
- acute coronary syndrome,
- hemophilia, and nephrogenic diabetes insipidus,
- allergy against desmopressin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Desmopressin on Platelet Function in CKD Patients on Antiplatelet Agent Who Need Emergent Temporary Catheter Insertion for Hemodialysis
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
- Being tested
- Desmopressin administration
- Medical subject headings
- Hemorrhage, Tachycardia, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desmopressin administrationDrug
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin | Experimental | Twenty five patients with chronic kidney disease and who were taking antiplatelet agents and needed an emergent catheter insertion for hemodialysis Receives: Drug: Desmopressin administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (1)
Bleeding after procedure
we observe incidence of bleeding complication after procedure
Measured: 1-4 hr after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startAug 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulsan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soon Bae Kim, M.D., PhD., University of Ulsan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841515
- Sponsor's protocol ID
- NCT00134031
- Status last verified
- May 2013
- First submitted
- 23 Apr 2013
- Last updated
- 13 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Desmopressin on Platelet Function in CKD Patients on Antiplatelet Agent Who Need Emergent Temporary Catheter Insertion for Hemodialysis
- ClinicalTrials.gov ID
- NCT01841515
- Acronym / sponsor ID
- NCT00134031
- Conditions
- Bleeding, Tachycardia, Dyspnea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of UlsanUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desmopressin | Experimental | Drug: Desmopressin administrationTwenty five patients with chronic kidney disease and who were taking antiplatelet agents and needed an emergent catheter insertion for hemodialysis |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult uremic patients with one or more antiplatelet medication,
- prolonged collagen/epinephrine (CEPI) closure time,
- need for emergent hemodialysis and
- subsequent catheter insertion
Key exclusion criteria (3 listed)
- acute coronary syndrome,
- hemophilia, and nephrogenic diabetes insipidus,
- allergy against desmopressin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desmopressin administration | Drug | Desmopressin |
Primary outcome
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.
1 secondary outcome
Bleeding after procedure
Time frame: 1-4 hr after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Desmopressin administration in people with Bleeding and Tachycardia, run by University of Ulsan at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
collagen-epinephrine closure time (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2013.