Clinical trial NCT04148404: Hypothermic Versus Normothermic Cardiac Bypass in Patients Undergoing CABG Surgery, Effect on Coagulation; Randomized Controlled Trial
Official title: Hypothermic Versus Normothermic Cardiac Bypass in Patients Undergoing CABG Surgery, Effect on Coagulation; Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CABG Surgery, Cold Blood Cardioplegia, Coagulation Profile and Platelet Function
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 86
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hypothermia may alter coagulation profile of patients undergoing CABG surgery; thus, affecting patients' outcome.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative alternations in the coagulation and haematological profile
timeFrame: One day Postoperative
Secondary outcomes:
measure: Amount of PO daily bleeding
timeFrame: One day Postoperative
measure: Number of transfused blood units
timeFrame: One day Postoperative
measure: Incidence of re-opening surgery due to bleeding
timeFrame: 24 hours Postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Abdalla Mohamed
Study officials:
References: