Platelet DysfunctionNCT03458351
RIPC and Platelet Activation on Platelet Activation During Cardiopulmonary Bypass
A study testing Remote ischemic preconditioning in people with Platelet Dysfunction, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In this study, the investigators are going to investigate the effects of remote ischemic preconditioning on platelet activation in patients undergoing cardiac surgery with cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Platelet Dysfunction
- What is being tested?
- Remote ischemic preconditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Mar 2018to 14 Aug 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing cardiac surgery with cardiopulmonary bypass
Who cannot join
- Preoperative left ventricle ejection fraction < 30%, mechanical ventricular support
- Peripheral vascular disease
- Poorly controlled diabetes mellitus
- NSAIDs within 3 days
- iv heparin within 6 h
- low molecular weight heparin within 24 h
Show all 11Show fewer
- platelet inhibitor within 24 h
- known thrombocytopenia
- End stage renal disease / hemodialysis
- Active infection
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Remote Ischemic Preconditioning on Platelet Activation During Cardiac Surgery With Cardiopulmonary Bypass
In this study, the investigators are going to investigate the effects of remote ischemic preconditioning on platelet activation in patients undergoing cardiac surgery with cardiopulmonary bypass.
Read the detailed description
Previous studies reported that remote ischemic conditioning reduce platelet activation in patients with coronary artery disease or patients undergoing ablation for atrial fibrillation. Cardiac surgery with cardiopulmonary bypass has been associated with platelet activation. In this randomized study, investigators are going to compare the effects of remote ischemic preconditioning (RIPC) on platelet activation using flow cytometry in patients undergoing cardiac surgery with cardiopulmonary bypass.
- Conditions
- Platelet Dysfunction
- Being tested
- Remote ischemic preconditioning, Sham control
- Keywords
- platelet activation, remote ischemic preconditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningDevice
Four cycles of 5 min of ischemia, which is induced by a blood pressure cuff in the upper arm inflated to 200 mmHg, followed by 5 min of reperfusion, during which the cuff is deflated.
Sham controlDevice
The same blood pressure cuff is placed around the upper arm, but the cuff is inflated to 10 mm Hg and ischemic preconditioning is not induced.
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic preconditioning | Active comparator | Remote ischemic conditioning after anesthesia induction
- four cycles of 5 min of ischemia followed by 5 min of reperfusion by inflation to 200 mm Hg and deflation of a blood pressure cuff on the upper arm Receives: Device: Remote ischemic preconditioning |
| Sham control | Sham comparator | The same blood pressure cuff is placed around the upper arm, but the cuff is inflated to 10mm Hg. Receives: Device: Sham control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet activation measured by CD62P expression using flow cytometry
CD62P AUC (area under the curve)
Measured: During 3hour after cardiopulmonary bypass initiation
Secondary outcomes (7)
Platelet activation measured by CD63 expression using flow cytometry
CD63 AUC (area under the curve)
Measured: During 3hour after cardiopulmonary bypass initiation
Platelet activation measured by monocyte-platelet aggregates (MPA) expression using flow cytometry
MPA AUC (area under the curve)
Measured: During 3hour after cardiopulmonary bypass initiation
Platelet activation measured by PAC1 expression using flow cytometry
PAC1 AUC (area under the curve)
Measured: During 3hour after cardiopulmonary bypass initiation
Platelet activation measured by platelet microparticles (PMP) expression using flow cytometry
PMP AUC (area under the curve)
Measured: During 3hour after cardiopulmonary bypass initiation
ADPtest by Multiplate® platelet function analyser
ADPtest AU
Measured: 3hour after cardiopulmonary bypass initiation
ASPItest by Multiplate® platelet function analyser
ASPItest AU
Measured: 3hour after cardiopulmonary bypass initiation
COLtest by Multiplate® platelet function analyser
COLtest AU
Measured: 3hour after cardiopulmonary bypass initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start28 Mar 2018
- Primary completion5 Aug 2019
- Study completion14 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet DysfunctionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunseok Jeon, Seoul National University Hospital
- Investigators
- Yunseok Jeon, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458351
- Sponsor's protocol ID
- RIPC_platelet activation
- Status last verified
- Oct 2019
- First submitted
- 22 Feb 2018
- Last updated
- 15 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Preconditioning on Platelet Activation During Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT03458351
- Acronym / sponsor ID
- RIPC_platelet activation
- Conditions
- Platelet Dysfunction
- Keywords
- platelet activation, remote ischemic preconditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 14 Aug 2019 (actual)
- First posted
- 8 Mar 2018 (actual)
- 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.
In this study, the investigators are going to investigate the effects of remote ischemic preconditioning on platelet activation in patients undergoing cardiac surgery with cardiopulmonary bypass.
Detailed description
Previous studies reported that remote ischemic conditioning reduce platelet activation in patients with coronary artery disease or patients undergoing ablation for atrial fibrillation. Cardiac surgery with cardiopulmonary bypass has been associated with platelet activation. In this randomized study, investigators are going to compare the effects of remote ischemic preconditioning (RIPC) on platelet activation using flow cytometry in patients undergoing cardiac surgery with cardiopulmonary bypass.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic preconditioning | Active comparator | Device: Remote ischemic preconditioningRemote ischemic conditioning after anesthesia induction - four cycles of 5 min of ischemia followed by 5 min of reperfusion by inflation to 200 mm Hg and deflation of a blood pressure cuff on the upper arm |
| Sham control | Sham comparator | Device: Sham controlThe same blood pressure cuff is placed around the upper arm, but the cuff is inflated to 10mm Hg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing cardiac surgery with cardiopulmonary bypass
Key exclusion criteria (11 listed)
- Preoperative left ventricle ejection fraction < 30%, mechanical ventricular support
- Peripheral vascular disease
- Poorly controlled diabetes mellitus
- NSAIDs within 3 days
- iv heparin within 6 h
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 |
|---|---|---|
| Remote ischemic preconditioningFour cycles of 5 min of ischemia, which is induced by a blood pressure cuff in the upper arm inflated to 200 mmHg, followed by 5 min of reperfusion, during which the cuff is deflated. | Device | Remote ischemic preconditioning |
| Sham controlThe same blood pressure cuff is placed around the upper arm, but the cuff is inflated to 10 mm Hg and ischemic preconditioning is not induced. | Device | Sham control |
Primary outcome
Platelet activation measured by CD62P expression using flow cytometry
Time frame: During 3hour after cardiopulmonary bypass initiation
CD62P AUC (area under the curve)
7 secondary outcomes
Platelet activation measured by CD63 expression using flow cytometry
Time frame: During 3hour after cardiopulmonary bypass initiation
Platelet activation measured by monocyte-platelet aggregates (MPA) expression using flow cytometry
Time frame: During 3hour after cardiopulmonary bypass initiation
Platelet activation measured by PAC1 expression using flow cytometry
Time frame: During 3hour after cardiopulmonary bypass initiation
Platelet activation measured by platelet microparticles (PMP) expression using flow cytometry
Time frame: During 3hour after cardiopulmonary bypass initiation
ADPtest by Multiplate® platelet function analyser
Time frame: 3hour after cardiopulmonary bypass initiation
ASPItest by Multiplate® platelet function analyser
Time frame: 3hour after cardiopulmonary bypass initiation
COLtest by Multiplate® platelet function analyser
Time frame: 3hour after cardiopulmonary bypass initiation
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 15 Oct 2019.
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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.
Yunseok Jeon principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic preconditioning in people with Platelet Dysfunction, run by Seoul National University Hospital 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 1 inclusion and 11 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 15 Oct 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Platelet activation measured by CD62P expression using flow cytometry (time frame: During 3hour after cardiopulmonary bypass initiation). 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 15 Oct 2019.