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

CABG Surgery, Cold Blood Cardioplegia, Coagulation Profile and Platelet Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04148404
• Other study ID #: Hypothermic vs normothermic
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: June 9, 2019

Study information

• Verified date: October 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 9, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• CABG Surgery, Cold Blood Cardioplegia, Coagulation Profile and Platelet Function
• Hypothermia

Intervention

Procedure:
• Normothermic group
Normothermic group (NT group) included patients will undergo CABG under warm bypass using warm blood cardioplegia (Normothermic CBP). Hypothermic group (HT group) included patients will undergo CABG under cold bypass using cold blood cardioplegia (Hypothermic CBP).

Locations

Country	Name	City	State
Egypt	Ahmed Abdalla Mohamed	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative alternations in the coagulation and haematological profile	Postoperative alternations in the coagulation and haematological profile	One day Postoperative
Secondary	Amount of PO daily bleeding	Amount of PO daily bleeding	One day Postoperative
Secondary	Number of transfused blood units	Number of transfused blood units	One day Postoperative
Secondary	Incidence of re-opening surgery due to bleeding	Incidence of re-opening surgery due to bleeding	24 hours Postoperative