Clinical Trials Logo
NCT number NCT03216720
Study type Interventional
Source Aarhus University Hospital Skejby
Contact Ivy Susanne Modrau, MD
Phone +45 24778856
Email ivy.modrau@skejby.rm.dk
Status Recruiting
Phase N/A
Start date September 28, 2017
Completion date January 2019

Clinical Trial Summary

Rationale:

Contemporary coronary artery bypass grafting (CABG) continues to be associated with a significant risk of postoperative bleeding. Utilization of miniaturized extracorporeal circulation (miECC) significantly reduces the risk of postoperative bleeding but the underlying mechanisms are poorly understood.

Primary Objective:

To assess the impact of miECC compared to conventional extracorporeal circulation (cECC) on thrombin generation as indicator of the overall haemostatic capacity after CABG.

Secondary Objectives To evaluate the impact of miECC versus cECC on blood loss and transfusion requirement, coagulation and fbrinolysis, inflammatory response, haemodilution and haemolysis, endorgan protection, seasibility and safety

Study design:

Single-center, double-blind, parallel-group randomized controlled trial

Study population:

60 Patients undergoing non-emergent primary isolated CABG with ECC randomized 1:1 to receive either miECC or cECC


Clinical Trial Description

Blood samples will be obtained at the following time points:

- T0; preoperative after induction of anaesthesia (after insertion of central venous line)

- T1; after weaning of the ECC prior to protaminization

- T2; 10 minutes after full protaminization

- T3; six hours after the end of the ECC

- T4; 1. postoperative day (16-20 hours following end of surgery)


Study Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Not yet recruiting NCT03259815 - How Often Can Optimal Post Percutaneous Coronary Intervention (PCI) Fractional Flow Reserve (FFR) Results be Achieved? N/A
Completed NCT01930214 - Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE) N/A
Recruiting NCT03198806 - Water Intake Associated With Aerobic Exercise in Coronary N/A
Recruiting NCT03265535 - Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging N/A
Not yet recruiting NCT02252783 - BFPET for Regional Myocardial Perfusion Imaging Phase 2
Not yet recruiting NCT03252990 - 18F-fluorocholine PET-MR Imaging of Coronary Plaque Vulnerability N/A
Not yet recruiting NCT03231527 - Outcomes of Total Arterial Coronary Artery Bypass Grafting N/A
Not yet recruiting NCT03265041 - Long Term Predictors of Graft Patency After Coronary Artery Bypass Graft Surgery (Multi-slice CT Coronary Angiography Study Validated by Coronary Angiography) N/A
Not yet recruiting NCT03284229 - Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA in CAD N/A
Recruiting NCT02693158 - The Direct III Post Market Study N/A
Recruiting NCT02814578 - Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation N/A
Recruiting NCT02922088 - EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits With DuraGraft [VASC] N/A
Recruiting NCT03027856 - The BIFSORB Pilot Study II N/A
Recruiting NCT02832115 - Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention Phase 4
Recruiting NCT02939729 - Physiotherapy Prehabilitation in Patients Undergoing Cardiac or Thoracic Surgery N/A
Enrolling by invitation NCT02894255 - Prospective Multicenter Registry of Hybrid Coronary Artery Revascularization Combined With Surgical Bypass and Percutaneous Coronary Intervention Using Everolimus Eluting Metallic Stents Phase 4
Enrolling by invitation NCT02806479 - Hypertrophic Cardiomyopathy Pilot Study N/A
Not yet recruiting NCT02863939 - Quantitation of Cardiac Output Change by Impedance Cardiography in Subjects Undergoing Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI N/A
Completed NCT03025685 - "Radial Ultra Support Technique" (RUS Technique) N/A
Not yet recruiting NCT02578355 - National Plaque Registry and Database N/A