Platelet FunctionNCT03125681
Remote Ischemic Conditioning and Platelet Dysfunction
A study testing Remote ischemic conditioning in people with Platelet Function, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the effects of remote ischemic conditioning on platelet function during off-pump coronary artery bypass surgery. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Platelet Function
- What is being tested?
- Remote ischemic conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 May 2017to 9 Feb 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 - 80 years of adult patient undergoing elective off-pump coronary artery bypass surgery
Who cannot join
- Acute Myocardial Infarction
- Recent (<1 month) coronary angioplasty (percutaneous coronary intervention, PCI)
- Acute cerebrovascular ischemia (<6 months)
- Preoperative LV EF < 30%, mechanical ventricular support (IABP, VAD, ECMO)
- Peripheral vascular disease
- Poorly controlled diabetes mellitus
Show all 17Show fewer
- Alzheimer's disease
- NSAIDs within 3 days
- iv heparin within 6 h
- low molecular weight heparin within 24 h
- platelet inhibitor within 24 h
- known thrombocytopenia
- renal failure / hemodialysis
- active infection
- preoperative bleeding diathesis
- redo-operation
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Remote Ischemic Conditioning on Platelet Dysfunction Following Off-pump Coronary Artery Bypass Surgery
The purpose of this study is to evaluate the effects of remote ischemic conditioning on platelet function during off-pump coronary artery bypass surgery.
Read the detailed description
Remote ischemic conditioning (RIC) may affect platelet function. However, little is known about effect of RIC on platelet function during off-pump coronary artery bypass surgery. In this study investigators are going to perform RIC after anesthesia induction (remote ischemic pre-conditioning) and after completion of coronary anastomoses (remote ischemic post-conditioning), and compare platelet function parameters with control group.
- Conditions
- Platelet Function
- Being tested
- Remote ischemic conditioning, Control
- Keywords
- remote ischemic conditioning, off-pump coronary artery bypass surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningProcedure or surgery
In the RIC group, RIC is performed before and after coronary anastomoses by 5 minutes limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times.
ControlProcedure or surgery
In the control group, all the procedures will be same with RIC group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase.
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic conditioning | Experimental | Applying pneumatic cuff on upper extremity (5 minutes cycles of limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times) before and after coronary anastomoses. Receives: Procedure: Remote ischemic conditioning |
| Control | Placebo comparator | All the procedures were the same in the control group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Multiplate ADPtest AUC
Area under the aggregation curve (AUC) after platelet stimulation with adenosine diphosphate
Measured: Baseline, at the end of surgery, postoperative day 1
Secondary outcomes (7)
Change of Multiplate ASPItest AUC
Area under the aggregation curve (AUC) after platelet stimulation with arachidonic acid
Measured: Baseline, at the end of surgery, postoperative day 1
Change of Multiplate COLtest AUC
Area under the aggregation curve (AUC) after platelet stimulation with collagen
Measured: Baseline, at the end of surgery, postoperative day 1
Change of Rotational thromboelastometry EXTEM parameter
Screening test for the extrinsic haemostasis system
Measured: Baseline, at the end of surgery, postoperative day 1
Change of Rotational thromboelastometry FIBTEM parameter
Represents an EXTEM based assay for the fibrin part of the clot
Measured: Baseline, at the end of surgery, postoperative day 1
Rotational thromboelastometry INTEM parameter
Intrinsically activated rotational thrombelastometry
Measured: Baseline, at the end of surgery, postoperative day 1
Change of Rotational thromboelastometry HEPTEM parameter
Represents an INTEM assay performed in the presence of heparinase
Measured: Baseline, at the end of surgery, postoperative day 1
Amount of peri-operative bleeding and transfusion
Amount of peri-operative bleeding and transfusion
Measured: At the end of surgery, postoperative day 1,2,3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start11 May 2017
- Primary completion31 Jan 2019
- Study completion9 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet FunctionStudies 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
- Double blind
- Who is masked
- Participant, 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, M.D., Ph. D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125681
- Sponsor's protocol ID
- RIPC_multiplate
- Status last verified
- Apr 2019
- First submitted
- 14 Apr 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remote Ischemic Conditioning on Platelet Dysfunction Following Off-pump Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT03125681
- Acronym / sponsor ID
- RIPC_multiplate
- Conditions
- Platelet Function
- Keywords
- remote ischemic conditioning, off-pump coronary artery bypass surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 11 May 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 9 Feb 2019 (actual)
- First posted
- 24 Apr 2017 (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.
The purpose of this study is to evaluate the effects of remote ischemic conditioning on platelet function during off-pump coronary artery bypass surgery.
Detailed description
Remote ischemic conditioning (RIC) may affect platelet function. However, little is known about effect of RIC on platelet function during off-pump coronary artery bypass surgery. In this study investigators are going to perform RIC after anesthesia induction (remote ischemic pre-conditioning) and after completion of coronary anastomoses (remote ischemic post-conditioning), and compare platelet function parameters with control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic conditioning | Experimental | Procedure: Remote ischemic conditioningApplying pneumatic cuff on upper extremity (5 minutes cycles of limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times) before and after coronary anastomoses. |
| Control | Placebo comparator | Procedure: ControlAll the procedures were the same in the control group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 20 - 80 years of adult patient undergoing elective off-pump coronary artery bypass surgery
Key exclusion criteria (17 listed)
- Acute Myocardial Infarction
- Recent (<1 month) coronary angioplasty (percutaneous coronary intervention, PCI)
- Acute cerebrovascular ischemia (<6 months)
- Preoperative LV EF < 30%, mechanical ventricular support (IABP, VAD, ECMO)
- Peripheral vascular disease
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 conditioningIn the RIC group, RIC is performed before and after coronary anastomoses by 5 minutes limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times. | Procedure or surgery | Remote ischemic conditioning |
| ControlIn the control group, all the procedures will be same with RIC group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase. | Procedure or surgery | Control |
Primary outcome
Change of Multiplate ADPtest AUC
Time frame: Baseline, at the end of surgery, postoperative day 1
Area under the aggregation curve (AUC) after platelet stimulation with adenosine diphosphate
7 secondary outcomes
Change of Multiplate ASPItest AUC
Time frame: Baseline, at the end of surgery, postoperative day 1
Change of Multiplate COLtest AUC
Time frame: Baseline, at the end of surgery, postoperative day 1
Change of Rotational thromboelastometry EXTEM parameter
Time frame: Baseline, at the end of surgery, postoperative day 1
Change of Rotational thromboelastometry FIBTEM parameter
Time frame: Baseline, at the end of surgery, postoperative day 1
Rotational thromboelastometry INTEM parameter
Time frame: Baseline, at the end of surgery, postoperative day 1
Change of Rotational thromboelastometry HEPTEM parameter
Time frame: Baseline, at the end of surgery, postoperative day 1
Amount of peri-operative bleeding and transfusion
Time frame: At the end of surgery, postoperative day 1,2,3
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 4 Apr 2019.
- Individual participant dataSharing planned: No
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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, M.D., Ph. D. 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 conditioning in people with Platelet Function, 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 17 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 4 Apr 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?
Change of Multiplate ADPtest AUC (time frame: Baseline, at the end of surgery, postoperative day 1). 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 4 Apr 2019.