A Pilot Randomized Controlled Trial on Incidence of Haemolysis during Cardiopulmonary Bypass on Adult Cardiac Surgeries

BACKGROUND

The utilization of cardiopulmonary bypass (CPB) is nearly inevitable in cardiac surgery. Yet, it can lead to complications such as hemolysis, which is a significant factor in postoperative kidney injury and intestinal mucosal damage, possibly by reducing NO-bioavailability. Various factors influence hemolysis during CPB, including the method of venous drainage, occlusion settings, type of pump, CPB duration, arterial line pressure, vacuum-assisted Venous drainage (VAVD) pressure, suction devices, type of cardiac surgery, hematocrit (Hct), and patient comorbidities. However, established standards for reducing hemolysis from CPB are lacking.

AIM

The study aims to delineate the risk factors that increase the incidence of hemolysis and establish a safe range of parameters according to our protocol to prevent hemolysis during CPB procedures.

METHODOLOGY

Study area: Cardiac OT of NICS

Study population: Adult Cardiac surgery patients of NICS

Study design: Randomized Controlled Trial

ETHICAL CLEARANCE

The study was approved by the scientific ethical committee and Narayana Health Ethics Committee (NHH/AEC-CL-2024-1306) and registered under the Clinical Trials Registry of India (CTRI) on 20th December 2024 (CTRI Number: CTRI/2024/12/078407).

Conclusion:

Our study concludes that strictly adhering to the study protocol in adult cardiac surgery patients undergoing CPB can help prevent hemolysis and improve patient outcomes by reducing complications associated with CPB-induced hemolysis. This applies to patients who have no renal impairments, no hemolytic disorders, and no pre-existing hemolysis, as well as those without cyanotic heart disease. Additionally, it is crucial that patients do not require a return to CPB, the surgery is not a redo procedure (particularly in cases involving mechanical valve implantation), and CPB is not initiated as an emergency.