Hypothermic Versus Normothermic Cardiac Bypass in Patients Undergoing CABG Surgery, Effect on Coagulation; Randomized Controlled Trial

Not Applicable

Completed

• Conditions: CABG Surgery, Cold Blood Cardioplegia, Coagulation Profile and Platelet Function
• Interventions: Procedure: Normothermic group

• Registration Number: NCT04148404
• Lead Sponsor: Cairo University

Brief Summary

On-pump CABG surgery deleteriously affects hematological and coagulation profiles of patients and this effect was accentuated by the use of cold bypass. PO altered platelet may count and function and prolonged clotting times correlates with amount of daily PO blood wound drainage and number of blood products units used, but prolonged aPTT is the best predictor for these events.

Detailed Description

Background: The use of cardiopulmonary bypass during cardiac surgery negatively affects the coagulation system. Hypothermia is also known to inhibit the coagulation profile. The aim of the study is to assess and compare the early postoperative (PO) haematological and coagulation profile of patients undergoing coronary artery bypass graft (CABG) surgery with Hypothermic (HT) versus normothermic (NT) bypass Methods: eighty-six patients were divided into two equal groups: NT group included patients received warm bypass and using warm blood cardioplegia from bypass and HT group included patients received cold bypass and using cold cardioplegia given by the anaesthesiologist. PO monitoring included the activated clotting time (ACT) prior to wound closure and 2-hr changes in the haemoglobin concentration (Hb), platelet count (PC), ADP-induced platelet aggregation (IPA), INR in relation to preoperative profile and amount of PO daily blood loss and number of transfused blood units. The primary outcome was the PO alternations in the coagulation and haematological profile. The secondary outcome was the amount of PO daily bleeding, number of transfused blood units and incidence of re-opening surgery due to bleeding.

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-09
• Status Verified: 2019-10
• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-30
• Last Update Submitted: 2019-10-31
• Study First Posted: 2019-11-01
• Last Update Posted: 2019-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

1. Ischemic heart disease patients
2. Both genders
3. Aged 50 - 65 years
4. Assigned for first-time, elective and isolated on-pump CABG surgery.

Exclusion Criteria

1. Pre-existing coagulopathy
2. Hemostasis disorders,
3. Anemia,
4. Redo or emergency CABG, re-exploration for surgical-cause PO bleeding, other associated pathologies, hepatic or renal impairment and/or maintenance on antiplatelet therapy during the last 10 days prior to surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group HT	Normothermic group	2.Hypothermic group (HT group) included patients will undergo CABG under cold bypass using cold blood cardioplegia (Hypothermic CBP).
Group NT	Normothermic group	1.Normothermic group (NT group) included patients will undergo CABG under warm bypass using warm blood cardioplegia (Normothermic CBP).

Primary Outcome Measures

Name	Time	Method
Postoperative alternations in the coagulation and haematological profile	One day Postoperative	Postoperative alternations in the coagulation and haematological profile

Secondary Outcome Measures

Name	Time	Method
Amount of PO daily bleeding	One day Postoperative	Amount of PO daily bleeding
Number of transfused blood units	One day Postoperative	Number of transfused blood units
Incidence of re-opening surgery due to bleeding	24 hours Postoperative	Incidence of re-opening surgery due to bleeding

Trial Locations

Locations (1)

Ahmed Abdalla Mohamed; 🇪🇬 Cairo, Egypt