Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03622671
Other study ID # K/ZDS/007961
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 26, 2018
Est. completion date February 10, 2020

Study information

Verified date February 2020
Source Jagiellonian University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Up to 15% of operations in cardio-pulmonary by-pass are complicated by excessive postoperative blood loss, which negatively affects the outcomes. Recently, it has been demonstrated that fibrin clot susceptibility to lysis is a modulator of postoperative blood loss after cardiac surgery for aortic stenosis. Earlier, a preliminary study showed a negative association of postoperative blood loss after coronary artery by-pass grafting (CABG) with fibrin clot lysis time, reflecting susceptibility to fibrinolysis.

In CABG, postoperative blood loss may depend on the operative technique with respect to left internal mammary artery (LIMA) harvesting. LIMA is taken down in virtually all CABG procedures, but harvesting technical details remain at surgeons discretion (skeletonization without opening the pleural cavity vs. pedicled graft with pleura wide open).

The investigators decided to test the hypothesis that fibrin clot properties modulate the postoperative drainage following CABG strongly enough to attenuate the influence of surgical technique by randomizing the patients undergoing CABG with regard to LIMA harvesting technique.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date February 10, 2020
Est. primary completion date December 24, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Angiographically confirmed coronary artery disease

- Heart Team qualification for first time elective coronary artery by-pass grafting

- No significant valvular disease or congenital heart disease

- Normal sinus rhythm on ECG

- Continued aspirin in perioperative period

Exclusion Criteria:

- Need for any concomitant cardiac procedure

- St. p. percutaneous coronary intervention within preceding 3 months

- Any previous cardiac surgery

- Known bleeding diathesis

- Acute cardiovascular incident within preceding 3 months

- Heart failure with left ventricular ejection fraction <30%

- Any autoimmune disease

- Any acute infection

- Known neoplasm

- Any thyroid disease

- Treatment with any thienopyridine, oral anticoagulant, heparin or any non-steroid anti-inflammatory agent other than aspirin

- Mental disorder

- Severe comorbidities (liver failure, renal failure on hemodialysis)

- Lacking consent

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Skeletonized LIMA
Standard CABG - no different form any other procedure of this type except LIMA will be skeletonized without opening the pleura
Pedicled LIMA
Standard CABG - no different form any other procedure of this type except LIMA will be taken down as a pedicled graft with opening the pleura

Locations

Country Name City State
Poland The John Paul II Hospital Kraków Malopolskie

Sponsors (1)

Lead Sponsor Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative chest-tube output after 12 hours Drainage volume after 12 hours 12 hours from the end of operation
Secondary Perioperative myocardial infarction Change in myocardial necrosis biomarkers (Troponin T, creatine kinase) during first 48 hours postoperatively 48 hours after the procedure
See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Coronary De Novo Lesions N/A