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A Comparative Study of Different Hypothermic Circulatory Arrest Strategies on Aortic Surgery.

Primary Purpose

Morality, Hypothermic Circulatory Arrest Time, Aortic-cross Clamping Time

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the temperature of hypothermic circulatory arrest
Sponsored by
Xiaoping Fan. MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morality focused on measuring Hyperthermic circulatory arrest; Surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1.Patients with confirmed diagnosis (i.e.aortic dissection, marfan syndrome, aortic arch aneurysm and so on), which require total aortic arch replacement.

Exclusion Criteria:

  1. Preoperative heart attack or coma.
  2. Patients with surgical contraindication, including but not limited to severe cardiac,pulmonary,renal or hepatic insufficiency.
  3. Pre-existing heart condition or neurological disease.
  4. Variation of aortic arch or its branch vessels.
  5. Patient is currently on anticoagulation therapy or has other medical condition that compromises the coagulation.
  6. Patient with active infection.
  7. Allergy to anaesthetic or contrast agent.
  8. Pregnant or lactating female.
  9. Patient is already on other medical trial.
  10. Other medical, psychological or socioeconomics condition determined by investigator that is not eligible for the study.

Sites / Locations

  • Guangdong General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mild hypothermia

Moderate hypothermia

Arm Description

Initiation of circulatory arrest using the cardiopulmonary bypass at temperature 28.1 - 34 degrees Celsius

Initiation of circulatory arrest using the cardiopulmonary bypass at temperature 20.1 - 28 degrees Celsius

Outcomes

Primary Outcome Measures

Mortality
In-hospital Mortality or other related death
Re-thoracotomy
Postoperative bleeding or other conditions require re-thoracotomy
Neurological disorder
Any neurological event occur after surgery, including transient and permanent.

Secondary Outcome Measures

HCA time
the time of hypothermic circulatory arrest
Aorta-cross clamp time
the time of aortic-cross clamp
CPB time
the time of cardiopulmonary bypass
Operation time
the time of the entire surgery.
ICU stay
the day of ICU treatment
Time of mechanical ventilation
the time of using respirator
Blood transfusion
the number of blood product during the hospitalization, including red blood cell, platelet, plasma and so on.
Dialysis
postoperative renal failure requiring dialysis
Hospital stay
the time of hospitalization
Postoperative aneurysm
Aortic aneurysm develope after the surgery
Postoperative endoleak
Stent-graft endoleak occurs after the surgery.

Full Information

First Posted
February 25, 2018
Last Updated
August 2, 2018
Sponsor
Xiaoping Fan. MD
Collaborators
Jie He.MD, Shihao Cai.MD, Wenda Gu.PhD, Haijiang Guo.PhD, Liang Hong. MD, Ruixing Fan.PhD, Jingsong Huang.PhD, Tucheng Sun.MD, Jihai Peng.MD
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1. Study Identification

Unique Protocol Identification Number
NCT03454633
Brief Title
A Comparative Study of Different Hypothermic Circulatory Arrest Strategies on Aortic Surgery.
Official Title
A Comparative Study of Mild Hypothermic Circulatory Arrest Versus Moderate Hypothermic Circulatory Arrest on Aortic Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 3, 2018 (Actual)
Primary Completion Date
February 15, 2020 (Anticipated)
Study Completion Date
December 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaoping Fan. MD
Collaborators
Jie He.MD, Shihao Cai.MD, Wenda Gu.PhD, Haijiang Guo.PhD, Liang Hong. MD, Ruixing Fan.PhD, Jingsong Huang.PhD, Tucheng Sun.MD, Jihai Peng.MD

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
By comparing the clinical outcome of patients underwent different hypothermic circulatory arrest (mild hypothermic versus moderate hypothermic) during aortic arch surgery, this study aims to determine the optimal hypothermic circulatory arrest strategy for aortic surgery.
Detailed Description
Hypothermic circulatory arrest (HCA) is the cornerstone of aortic surgery. It provides a bloodless and still operative field. But the side effect of hypothermia also draws people's concern. With the development of surgical techniques and cardiopulmonary bypass (CPB) management, the temperature of HCA has been raised from deep hypothermia (14.1-20 degree) to moderate hypothermia (20.1-28 degree), and it has been a primary choice for many surgeons around the world. Some of surgeons still tried to push the limit and started using mild hypothermia (28.1-34 degree), and satisfactory outcome was obtained. However, the optimal temperature of HCA has not yet been determined. In this randomized controlled study, 80 informed and consenting patients who are scheduled for total arch replacement with concomitant proximal aortic reconstruction will be randomized to mild (28.1-34 degree) or moderate (20.1-28 degree) hypothermia during circulatory arrest. Clinical outcomes of both groups will be analyzed to determine the optimal temperature for HCA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morality, Hypothermic Circulatory Arrest Time, Aortic-cross Clamping Time, Cardiopulmonary Bypass Time, Operation Time, Re-Thoracotomy, ICU Stay, Mechanical Ventilation Time, Blood Transfusion, Neurological Disorder, Dialysis, Aneurysm, Endoleak, Hospital Stay
Keywords
Hyperthermic circulatory arrest; Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomised controlled study
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mild hypothermia
Arm Type
Experimental
Arm Description
Initiation of circulatory arrest using the cardiopulmonary bypass at temperature 28.1 - 34 degrees Celsius
Arm Title
Moderate hypothermia
Arm Type
Active Comparator
Arm Description
Initiation of circulatory arrest using the cardiopulmonary bypass at temperature 20.1 - 28 degrees Celsius
Intervention Type
Procedure
Intervention Name(s)
the temperature of hypothermic circulatory arrest
Intervention Description
Different temperature (mild 30 degree or moderate 25 degree) employed during the hypothermic circulatory arrest on aortic surgery.
Primary Outcome Measure Information:
Title
Mortality
Description
In-hospital Mortality or other related death
Time Frame
3 months within surgery.
Title
Re-thoracotomy
Description
Postoperative bleeding or other conditions require re-thoracotomy
Time Frame
Through the hospitalization, an average of 4 weeks.
Title
Neurological disorder
Description
Any neurological event occur after surgery, including transient and permanent.
Time Frame
Through the hospitalization, an average of 4 weeks.
Secondary Outcome Measure Information:
Title
HCA time
Description
the time of hypothermic circulatory arrest
Time Frame
During the operation
Title
Aorta-cross clamp time
Description
the time of aortic-cross clamp
Time Frame
During the operation
Title
CPB time
Description
the time of cardiopulmonary bypass
Time Frame
During the operation
Title
Operation time
Description
the time of the entire surgery.
Time Frame
During the operation
Title
ICU stay
Description
the day of ICU treatment
Time Frame
Through the ICU stay, an average of 1 weeks.
Title
Time of mechanical ventilation
Description
the time of using respirator
Time Frame
Through the use of ventilation, an average of 3 days.
Title
Blood transfusion
Description
the number of blood product during the hospitalization, including red blood cell, platelet, plasma and so on.
Time Frame
Through the hospitalization, an average of 4 weeks.
Title
Dialysis
Description
postoperative renal failure requiring dialysis
Time Frame
Through the hospitalization, an average of 4 weeks.
Title
Hospital stay
Description
the time of hospitalization
Time Frame
Through the hospitalization, an average of 4 weeks.
Title
Postoperative aneurysm
Description
Aortic aneurysm develope after the surgery
Time Frame
1 year within the surgery
Title
Postoperative endoleak
Description
Stent-graft endoleak occurs after the surgery.
Time Frame
1 year within the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.Patients with confirmed diagnosis (i.e.aortic dissection, marfan syndrome, aortic arch aneurysm and so on), which require total aortic arch replacement. Exclusion Criteria: Preoperative heart attack or coma. Patients with surgical contraindication, including but not limited to severe cardiac,pulmonary,renal or hepatic insufficiency. Pre-existing heart condition or neurological disease. Variation of aortic arch or its branch vessels. Patient is currently on anticoagulation therapy or has other medical condition that compromises the coagulation. Patient with active infection. Allergy to anaesthetic or contrast agent. Pregnant or lactating female. Patient is already on other medical trial. Other medical, psychological or socioeconomics condition determined by investigator that is not eligible for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoping Fan, PhD
Organizational Affiliation
Guangdong General Hosiptal
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jie He, MD
Organizational Affiliation
Guangdong General Hosiptal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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A Comparative Study of Different Hypothermic Circulatory Arrest Strategies on Aortic Surgery.

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