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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04309994
Other study ID # 2019-02383; ch20Reuthebuch
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2010
Est. completion date January 2020

Study information

Verified date March 2020
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this study is to compare the two cardioplegia solutions (blood cardioplegia by means of MPS ® vs. Cardioplexol ®) regarding perioperative outcome and with special attention to cardiac markers in patients with a recent heart attack.


Recruitment information / eligibility

Status Completed
Enrollment 307
Est. completion date January 2020
Est. primary completion date January 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients who underwent a CABG using MPS® or Cardioplexol ®

- Heart attack less than 7 days before surgery

Exclusion Criteria:

- use of other cardioplegia solution than Cardioplexol ® or MPS®

- other inventions than CABG

- explicit will of the patient that his data may not be used

- denied general consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Myocardial protection system (MPS)
cardioplegia solution, A separate pumpsystem by which Blood cardioplegia with individually composable additives as cardioplegia solution can be used
Cardioplexol
cardioplegia solution

Locations

Country Name City State
Switzerland Cardiac Surgery Clinic University Hospital Basel Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary myocardial damage Analyse cardiac biomarkers as indicators for myocardial damage: high sensitive troponin (Ths-TrT, ng/mL), creatine kinase (CK, in ng/mL) and creatine kinase-MB isoenzyme (CK-MB, in ng/mL) patients with that received a coronary artery bypass grafting and that were treated (for approximately 15 days) at the University Hospital between February 2010 and January 2020 (data taken perioperative during hospital stay for CABG)
Secondary 30 days Mortality death after coronary artery bypass grafting 30 days after CABG
Secondary length of stay in the intensive care unit duration of stay at intensive care unit perioperative during hospital stay for CABG (for approximately 15 days)
Secondary Number of participants with bleedings bleeding complication after coronary artery bypass grafting perioperative during hospital stay for CABG (for approximately 15 days)
Secondary Number of participants with postoperative arrhythmia rhythm disturbance after coronary artery bypass grafting perioperative during hospital stay for CABG (for approximately 15 days)
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