On-pump Beating Coronary Artery Bypass Grafting by Ventricular Assist

NCT02731794 | Unknown Phase 4 DMC

• 1 other identifier: HenanICE201602
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators designed the randomized prospective study to evaluate the differences of inflammatory response and clinical outcome after on-pump beating coronary artery bypass grafting undergoing left ventricular assist versus biventricular assist in patients with severe left ventricle dysfunction.

Conditions

Coronary Artery Bypass

Keywords

cardiopulmonary bypass; coronary artery bypass grafting; inflammatory response; cardiac dysfunction

Outcome Measures

Primary Outcomes (1)

• Changes of C-reactive protein (CRP)

  Serial blood samples for inflammatory response of CRP were collected at the following time points: 1: induction of anesthesia, 2: upon termination of cardiopulmonary bypass (CPB), 3: 6 hours postoperatively, 4: 24 hours postoperatively, 5: 48 hours postoperatively, 6: 72 hours postoperatively.

  up tp 72 hours

Secondary Outcomes (6)

• Incidence of atrial fibrillation

  10 days

• Durations of mechanical ventilation

  10 days

• The number for transfused packed red cells

  up to 10 days

• Partial oxygen pressure/inspired oxygen fraction (P/F)

  up tp 10 days

• Cardiac Troponin I (cTnI)

  up to72 hours

Study Arms (2)

LVA group

EXPERIMENTAL

LVA group: left ventricular assist group.

Device: left ventricular assist

BiVA group

ACTIVE COMPARATOR

BiVA group: Biventricular assist group.

Procedure: Biventricular assist

Interventions

left ventricular assist DEVICE

In left ventricular assist group, 100 IU/kg heparin was given to activated clotting time (ACT) greater than 180 seconds. A 22 French arterial cannula (Maquet, Irrlingen, Germany) was introduced into the ascending aorta, and a 26 French cannula (Eurosets, Medolla, Italy) into the left atrium and advanced into the left ventricle. The two cannulas are directly connected through a short, heparin-coated circuit to a centrifuge pump (Maquet, Getinge Group, Germany). A flow of 1.0 to 4.0 L/min/m2 is obtained and mean blood pressure was maintained 55-75 mm Hg. Note: Both LVA group and BiVA group have the operative protocols itself,includes different prime fluid and cannula pathway. The investigators think it is inapplicable to assign the different operative protocols to the Treatment Arm.

LVA group

Biventricular assist PROCEDURE

In biventricular assist group, the patients were routinely heparinized with a dose of 300 IU/kg heparin to ACT greater than 480 seconds. Cardiopulmonary bypass with a centrifuge pump (Maquet, Getinge Group, Germany) was established by 22 French aortic cannulation and 34 French two-stage venous cannula through the right atrial appendage. The extracorporeal circuit was primed with 2000 mL of lactated Ringer's solution, albumin, 25% mannitol and 5% NaHCO3. The flow was 1.0 to 4.0 L/min/m2 and mean blood pressure was maintained 55-75 mm Hg.

BiVA group

Eligibility Criteria

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

You may qualify if:

• patients with severe left ventricle dysfunction with an ejection fraction (EF)≤40%, being scheduled for revascularization.

You may not qualify if:

• myocardial infarction within the preceding 4 weeks
• severe valve disease requiring valve replacement
• cardiac reoperations

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Sites (1)

Henan Provincial People' Hospital

Zhengzhou, Henan, 450003, China

Location

Related Publications (10)

• Lim E, Drain A, Davies W, Edmonds L, Rosengard BR. A systematic review of randomized trials comparing revascularization rate and graft patency of off-pump and conventional coronary surgery. J Thorac Cardiovasc Surg. 2006 Dec;132(6):1409-13. doi: 10.1016/j.jtcvs.2006.08.012.

  PMID: 17140968 RESULT

• Urso S, Sadaba JR, Pettinari M. Impact of off-pump to on-pump conversion rate on post-operative results in patients undergoing off-pump coronary artery bypass. Interact Cardiovasc Thorac Surg. 2012 Feb;14(2):188-93. doi: 10.1093/icvts/ivr071. Epub 2011 Nov 28.

  PMID: 22159253 RESULT

• Fujii T, Watanabe Y, Shiono N, Kawasaki M, Yokomuro H, Ozawa T, Hamada S, Masuhara H, Teramoto T, Hara M, Katayanagi T, Sasaki Y, Koyama N. Assessment of on-pump beating coronary artery bypass surgery performed after introduction of off-pump approach. Ann Thorac Cardiovasc Surg. 2006 Oct;12(5):324-32.

  PMID: 17095974 RESULT

• Erkut B, Dag O, Kaygin MA, Senocak M, Limandal HK, Arslan U, Kiymaz A, Aydin A, Kahraman N, Calik ES. On-pump beating-heart versus conventional coronary artery bypass grafting for revascularization in patients with severe left ventricular dysfunction: early outcomes. Can J Surg. 2013 Dec;56(6):398-404. doi: 10.1503/cjs.018412.

  PMID: 24284147 RESULT

• Mazzei V, Nasso G, Salamone G, Castorino F, Tommasini A, Anselmi A. Prospective randomized comparison of coronary bypass grafting with minimal extracorporeal circulation system (MECC) versus off-pump coronary surgery. Circulation. 2007 Oct 16;116(16):1761-7. doi: 10.1161/CIRCULATIONAHA.107.697482. Epub 2007 Sep 17.

  PMID: 17875971 RESULT

• Al Jaaly E, Chaudhry UA, Harling L, Athanasiou T. Should we consider beating-heart on-pump coronary artery bypass grafting over conventional cardioplegic arrest to improve postoperative outcomes in selected patients? Interact Cardiovasc Thorac Surg. 2015 Apr;20(4):538-45. doi: 10.1093/icvts/ivu425. Epub 2014 Dec 21.

  PMID: 25535178 RESULT

• Stassano P, Di Tommaso L, Monaco M, Iesu S, Brando G, Buonpane S, Ambrosio G, Di Benedetto G, Pepino P. Myocardial revascularization by left ventricular assisted beating heart is associated with reduced systemic inflammatory response. Ann Thorac Surg. 2009 Jan;87(1):46-52. doi: 10.1016/j.athoracsur.2008.07.098.

  PMID: 19101266 RESULT

• Gulcan O, Turkoz R, Turkoz A, Caliskan E, Sezgin AT. On-pump/beating-heart myocardial protection for isolated or combined coronary artery bypass grafting in patients with severe left ventricle dysfunction: assessment of myocardial function and clinical outcome. Heart Surg Forum. 2005;8(3):E178-82; discussion E183. doi: 10.1532/HSF98.20041166.

  PMID: 15937002 RESULT

• Ferrari E, Stalder N, von Segesser LK. On-pump beating heart coronary surgery for high risk patients requiring emergency multiple coronary artery bypass grafting. J Cardiothorac Surg. 2008 Jul 2;3:38. doi: 10.1186/1749-8090-3-38.

  PMID: 18597673 RESULT

• Folliguet TA, Philippe F, Larrazet F, Dibie A, Czitrom D, Le Bret E, Bachet J, Laborde F. Beating heart revascularization with minimal extracorporeal circulation in patients with a poor ejection fraction. Heart Surg Forum. 2002;6(1):19-23. doi: 10.1532/hsf.992.

  PMID: 12611727 RESULT

Study Officials

• Zhaoyun Cheng, MD

  Henan Provincial People' Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: March 20, 2016
• First Posted: April 8, 2016
• Study Start: May 1, 2016
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)