Study on CRP Apheresis After Coronary Bypass Surgery

NCT04745468 | Completed

• 1 other identifier: P02 CABY1
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Tissue damage of the heart

  Daily determination of the concentration of the biomarker Troponin I (hsTnI)

  Every 24 hours for up to 96 hours after bypass surgery

Secondary Outcomes (7)

• Safety of CRP apheresis

  24 hours after each apheresis

• Cardiac events

  Until the patient is discharged from the hospital, an average of 7 days

• Tissue damage of the heart with Procalcitonin

  Every 24 hours for 72 hours after bypass surgery

• Tissue damage of the heart with CK-MB

  Every 24 hours for 72 hours after bypass surgery

• Tissue damage of the heart with Myoglobin

  Every 24 hours for 72 hours after bypass surgery

Study Arms (2)

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.

Device: CRP apheresis

Control group

NO INTERVENTION

17 patients of the control group receive the standard therapy after bypass surgery.

Interventions

CRP apheresis DEVICE

Selective CRP apheresis by use of the PentraSorb-CRP adsorber

Apheresis Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective, isolated, primary coronary bypass surgery
• 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)
• Standard anesthesia (isoflurane)
• Intraoperative standard protocol (500 mg ASA after 2 h, low dose heparinization after 4 h)
• written informed consent
• legal capacity

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Pentracor GmbH: lead

Study Sites (1)

Klinik für Thorax- und Kardiovaskuläre Chirurgie

Essen, 45122, Germany

Location

Study Officials

• Matthias Thielmann, Prof. Dr. med.

  Westdeutsches Herz- und Gefäßzentrum Essen, Klinik für Thorax- und Kardiovaskuläre Chirurgie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: February 9, 2021
• Study Start: March 21, 2018
• Primary Completion: January 28, 2021
• Study Completion: January 28, 2021
• Last Updated: October 18, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)