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Completed

NCT Number: NCT04148404

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

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.

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Key information

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pre-existing coagulopathy
  • Hemostasis disorders,
  • Anemia,
  • 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

Treatment and study plan

Normothermic group

Procedure
  • 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).

Other names: Hypothermic group

Primary outcomes

  1. Postoperative alternations in the coagulation and haematological profile

    Time frame: One day Postoperative

    Postoperative alternations in the coagulation and haematological profile

Secondary outcomes

  1. Amount of PO daily bleeding

    Time frame: One day Postoperative

    Amount of PO daily bleeding

  2. Number of transfused blood units

    Time frame: One day Postoperative

    Number of transfused blood units

  3. Incidence of re-opening surgery due to bleeding

    Time frame: 24 hours Postoperative

    Incidence of re-opening surgery due to bleeding

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 1, 2019
Registry last updated
Nov 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.