Post-cardiac SurgeryCABY1NCT04745468
Study on CRP Apheresis After Coronary Bypass Surgery
A study testing CRP apheresis in people with Post-cardiac Surgery, run by Pentracor GmbH at 1 site in Germany.
Trial summary
The CABY1 study is conducted open, controlled, randomized and monocentric. The efficacy and tolerability of CRP apheresis in patients undergoing elective primary coronary bypass surgery is investigated. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post-cardiac Surgery
- What is being tested?
- CRP apheresis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteGermany
- Study dates
- 21 Mar 2018to 28 Jan 2021
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective, isolated, primary coronary bypass surgery
- 2 or 3-fold CHD with or without main stem stenosis
- Obtained LVEF (> 30%, trans-oesophageal echocardiography (TEE) or angiography)
- Heart-lung machine (HLM; 'two-stage' cannulation)
- Antegrade Bretschneider cardioplegia
- Mild hypothermia (32 °C)
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- Standard anesthesia (isoflurane)
- Intraoperative standard protocol (500 mg ASA after 2 h, low dose heparinization after 4 h)
- written informed consent
- legal capacity
Who cannot join
- Preoperatively
- PCI (within last 2 weeks)
- Renal insufficiency (creatinine > 1.3 mmol/L or requiring dialysis)
- Combination interventions
- Re-surgery
- Emergency of urgent surgery indication
Show all 28Show fewer
- Acute coronary syndrome (IAP, NSTEMI, STEMI)
- Preoperatively positive hs-troponin I > 40 ng/ml
- Chronic arterial fibrillation
- Acute infectious disease (body temperature > 38.0°C)
- Systolic blood pressure < 100 mmHg
- Known hypersensitivity to therapeutic apheresis
- Cardiac shock
- Pregnancy or lactation
- Participation in other interventional trial
- During surgery
- Radialis removal
- Coronary TEA (if blood flow within bypass < 20 ml/min)
- Off-pump
- Hemofiltration
- Combination intervention (e.g. mitral valve reconstruction, LAA)
- Maze procedure
- Bypass low-flow closure, ECG changes
- Antithrombotic therapy (intraoperative clopidogrel and/or aspirin)
- Second HLM
- Second cardioplegic cardiac arrest
- Intraaortal balloon pumping / balloon pulsation (IABP)
- Extracorporeal membrane oxygenation (ECMO)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selective Depletion of C-reactive Protein by Therapeutic Apheresis (CRP Apheresis) After Elective Primary Coronary Bypass Surgery
The CABY1 study is conducted open, controlled, randomized and monocentric. The efficacy and tolerability of CRP apheresis in patients undergoing elective primary coronary bypass surgery is investigated.
Read the detailed description
CABY1 is a clinical trial to study the reduction of C-reactive protein (CRP) by therapeutic apheresis (CRP apheresis) in patients undergoing elective primary coronary bypass surgery.
The term therapeutic apheresis describes therapeutical procedures whose effect is based on the elimination of blood components with a pathogenic function within the disease process. Elimination takes place in adsorbers outside the body in an extracorporeal circuit. To remove the pathogenic substances, blood plasma is separated from the circuit and passed through an adsorber. The purified blood plasma is then reunited with the solid blood components and returned to the patient.
The "PentraSorb® CRP" adsorber used for CRP apheresis is CE-certified. It serves for the selective depletion of the C-reactive protein from human plasma.
As a cause of the damaging effect of the C-reactive protein it is assumed that the CRP as an inflammatory mediator favours the destruction of cardiac muscle tissue (in conjunction with complement) and has a negative influence on the regeneration of the traumatized tissue.
The aim of the CABY1 study is to investigate if the tissue damage of the heart can be reduced by depletion of the C-reactive protein after elective coronary bypass surgery. A possible protective effect of CRP apheresis will be determined from laboratory biomarkers (e.g., troponin I, CM-MB, IL-6) and cardiac events.
20 randomly selected patients receive apheresis treatments with a duration of 4-6 h each the following 2-3 days after bypass surgery, the 20 patients of the controls do not receive apheresis. The biomarkers required for the evaluation of the treatment success are determined over a period of 4 days after surgery on the basis of the routine blood tests. Cardiac events are documented until the patient is discharged.
- Conditions
- Post-cardiac Surgery
- Being tested
- CRP apheresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRP apheresisDevice
Selective CRP apheresis by use of the PentraSorb-CRP adsorber
| Study group | Role | What they receive |
|---|---|---|
| Apheresis Group | Experimental | 20 patients receive 2 apheresis treatments at intervals of 24 ± 12 h (additionally to the standard therapy after bypass surgery). The first treatment starts within 24 h postoperatively. If the CRP concentration increases to at least 30 mg/L 6-18 h after the end of the second treatment, a third treatment is performed.
For each treatment the 1 - 2.5-fold plasma void is processed. The duration of each treatment is 4-6 h. Receives: Device: CRP apheresis |
| Control group | No intervention | 17 patients of the control group receive the standard therapy after bypass surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue damage of the heart
Daily determination of the concentration of the biomarker Troponin I (hsTnI)
Measured: Every 24 hours for up to 96 hours after bypass surgery
Secondary outcomes (7)
Safety of CRP apheresis
Incidence of expected and unexpected adverse effects
Measured: 24 hours after each apheresis
Cardiac events
Documentation of cardiac events:
- Cardiac arrythmias
- Perioperative myocardial infarction (PMI)
- Cardiopulmonary resuscitation (CPR)
- Low cardiac output syndrome (LCOS)
- Re-surgery
- Percutaneous coronary intervention (PCI)
- Angina pectoris
Measured: Until the patient is discharged from the hospital, an average of 7 days
Tissue damage of the heart with Procalcitonin
Daily determination of the concentration of:
- Procalcitonin
Measured: Every 24 hours for 72 hours after bypass surgery
Tissue damage of the heart with CK-MB
Daily determination of the concentration of:
- Creatine kinase, MB fraction (CK-MB)
Measured: Every 24 hours for 72 hours after bypass surgery
Tissue damage of the heart with Myoglobin
Daily determination of the concentration of:
- Myoglobin
Measured: Every 24 hours for 72 hours after bypass surgery
Tissue damage of the heart with Leukocytes
Daily determination of the concentration of:
- Leukocytes
Measured: Every 24 hours for 72 hours after bypass surgery
Tissue damage of the heart with Interleukin-6
Daily determination of the concentration of:
- Interleukin-6 (IL-6)
Measured: Every 24 hours for 72 hours after bypass surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start21 Mar 2018
- Primary completion28 Jan 2021
- Study completion28 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-cardiac SurgeryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pentracor GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthias Thielmann, Prof. Dr. med., Principal investigator, Westdeutsches Herz- und Gefäßzentrum Essen, Klinik für Thorax- und Kardiovaskuläre Chirurgie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745468
- Sponsor's protocol ID
- P02 CABY1
- Acronym
- CABY1
- Status last verified
- Feb 2021
- First submitted
- 3 Dec 2020
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Depletion of C-reactive Protein by Therapeutic Apheresis (CRP Apheresis) After Elective Primary Coronary Bypass Surgery
- ClinicalTrials.gov ID
- NCT04745468
- Acronym / sponsor ID
- CABY1 / P02 CABY1
- Conditions
- Post-cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Pentracor GmbHIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 28 Jan 2021 (actual)
- Study completion
- 28 Jan 2021 (actual)
- First posted
- 9 Feb 2021 (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 CABY1 study is conducted open, controlled, randomized and monocentric. The efficacy and tolerability of CRP apheresis in patients undergoing elective primary coronary bypass surgery is investigated.
Detailed description
CABY1 is a clinical trial to study the reduction of C-reactive protein (CRP) by therapeutic apheresis (CRP apheresis) in patients undergoing elective primary coronary bypass surgery.
The term therapeutic apheresis describes therapeutical procedures whose effect is based on the elimination of blood components with a pathogenic function within the disease process. Elimination takes place in adsorbers outside the body in an extracorporeal circuit. To remove the pathogenic substances, blood plasma is separated from the circuit and passed through an adsorber. The purified blood plasma is then reunited with the solid blood components and returned to the patient.
The "PentraSorb® CRP" adsorber used for CRP apheresis is CE-certified. It serves for the selective depletion of the C-reactive protein from human plasma.
As a cause of the damaging effect of the C-reactive protein it is assumed that the CRP as an inflammatory mediator favours the destruction of cardiac muscle tissue (in conjunction with complement) and has a negative influence on the regeneration of the traumatized tissue.
The aim of the CABY1 study is to investigate if the tissue damage of the heart can be reduced by depletion of the C-reactive protein after elective coronary bypass surgery. A possible protective effect of CRP apheresis will be determined from laboratory biomarkers (e.g., troponin I, CM-MB, IL-6) and cardiac events.
20 randomly selected patients receive apheresis treatments with a duration of 4-6 h each the following 2-3 days after bypass surgery, the 20 patients of the controls do not receive apheresis. The biomarkers required for the evaluation of the treatment success are determined over a period of 4 days after surgery on the basis of the routine blood tests. Cardiac events are documented until the patient is discharged.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apheresis Group | Experimental | Device: CRP apheresis20 patients receive 2 apheresis treatments at intervals of 24 ± 12 h (additionally to the standard therapy after bypass surgery). The first treatment starts within 24 h postoperatively. If the CRP concentration increases to at least 30 mg/L 6-18 h after the end of the second treatment, a third treatment is performed. For each treatment the 1 - 2.5-fold plasma void is processed. The duration of each treatment is 4-6 h. |
| Control group | No intervention | –17 patients of the control group receive the standard therapy after bypass surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- elective, isolated, primary coronary bypass surgery
- 2 or 3-fold CHD with or without main stem stenosis
- Obtained LVEF (> 30%, trans-oesophageal echocardiography (TEE) or angiography)
- Heart-lung machine (HLM; 'two-stage' cannulation)
- Antegrade Bretschneider cardioplegia
Key exclusion criteria (28 listed)
- Preoperatively
- PCI (within last 2 weeks)
- Renal insufficiency (creatinine > 1.3 mmol/L or requiring dialysis)
- Combination interventions
- Re-surgery
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 |
|---|---|---|
| CRP apheresisSelective CRP apheresis by use of the PentraSorb-CRP adsorber | Device | Apheresis Group |
Primary outcome
Tissue damage of the heart
Time frame: Every 24 hours for up to 96 hours after bypass surgery
Daily determination of the concentration of the biomarker Troponin I (hsTnI)
7 secondary outcomes
Safety of CRP apheresis
Time frame: 24 hours after each apheresis
Cardiac events
Time frame: Until the patient is discharged from the hospital, an average of 7 days
Tissue damage of the heart with Procalcitonin
Time frame: Every 24 hours for 72 hours after bypass surgery
Tissue damage of the heart with CK-MB
Time frame: Every 24 hours for 72 hours after bypass surgery
Tissue damage of the heart with Myoglobin
Time frame: Every 24 hours for 72 hours after bypass surgery
Tissue damage of the heart with Leukocytes
Time frame: Every 24 hours for 72 hours after bypass surgery
Tissue damage of the heart with Interleukin-6
Time frame: Every 24 hours for 72 hours after bypass surgery
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 18 Oct 2022.
- 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.
Matthias Thielmann, Prof. Dr. med. principal investigator
Westdeutsches Herz- und Gefäßzentrum Essen, Klinik für Thorax- und Kardiovaskuläre Chirurgie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CRP apheresis in people with Post-cardiac Surgery, run by Pentracor GmbH at 1 site in Germany.
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 10 inclusion and 28 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 18 Oct 2022. 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 Germany. 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.
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?
Tissue damage of the heart (time frame: Every 24 hours for up to 96 hours after bypass surgery). 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 18 Oct 2022.