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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Normothermic group
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for CABG Surgery, Cold Blood Cardioplegia, Coagulation Profile and Platelet Function

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ahmed Abdalla Mohamed

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group NT

Group HT

Arm Description

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).

Outcomes

Primary Outcome Measures

Postoperative alternations in the coagulation and haematological profile
Postoperative alternations in the coagulation and haematological profile

Secondary Outcome Measures

Amount of PO daily bleeding
Amount of PO daily bleeding
Number of transfused blood units
Number of transfused blood units
Incidence of re-opening surgery due to bleeding
Incidence of re-opening surgery due to bleeding

Full Information

First Posted
October 28, 2019
Last Updated
October 31, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04148404
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CABG Surgery, Cold Blood Cardioplegia, Coagulation Profile and Platelet Function

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Hypothermia may alter coagulation profile of patients undergoing CABG surgery; thus, affecting patients' outcome.
Masking
ParticipantCare Provider
Masking Description
sealed opaque envelopes prepared by an assistant blinded about the study targets and chosen by patient him/herself, allocated into two groups
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group NT
Arm Type
Active Comparator
Arm Description
1.Normothermic group (NT group) included patients will undergo CABG under warm bypass using warm blood cardioplegia (Normothermic CBP).
Arm Title
Group HT
Arm Type
Active Comparator
Arm Description
2.Hypothermic group (HT group) included patients will undergo CABG under cold bypass using cold blood cardioplegia (Hypothermic CBP).
Intervention Type
Procedure
Intervention Name(s)
Normothermic group
Other Intervention Name(s)
Hypothermic group
Intervention Description
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).
Primary Outcome Measure Information:
Title
Postoperative alternations in the coagulation and haematological profile
Description
Postoperative alternations in the coagulation and haematological profile
Time Frame
One day Postoperative
Secondary Outcome Measure Information:
Title
Amount of PO daily bleeding
Description
Amount of PO daily bleeding
Time Frame
One day Postoperative
Title
Number of transfused blood units
Description
Number of transfused blood units
Time Frame
One day Postoperative
Title
Incidence of re-opening surgery due to bleeding
Description
Incidence of re-opening surgery due to bleeding
Time Frame
24 hours Postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ahmed Abdalla Mohamed
City
Cairo
ZIP/Postal Code
11451
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Till ending our work

Learn more about this trial

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

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