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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04148404
Enrollment
86
Registered
2019-11-01
Start date
2019-02-01
Completion date
2019-06-09
Last updated
2019-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDURENormothermic group

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)

Masking description

sealed opaque envelopes prepared by an assistant blinded about the study targets and chosen by patient him/herself, allocated into two groups

Intervention model description

Hypothermia may alter coagulation profile of patients undergoing CABG surgery; thus, affecting patients' outcome.

Eligibility

Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative alternations in the coagulation and haematological profileOne day PostoperativePostoperative alternations in the coagulation and haematological profile

Secondary

MeasureTime frameDescription
Amount of PO daily bleedingOne day PostoperativeAmount of PO daily bleeding
Incidence of re-opening surgery due to bleeding24 hours PostoperativeIncidence of re-opening surgery due to bleeding
Number of transfused blood unitsOne day PostoperativeNumber of transfused blood units

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026