NCT03454633

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

August 3, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

August 6, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

February 25, 2018

Last Update Submit

August 2, 2018

Conditions

MoralityHypothermic Circulatory Arrest TimeAortic-cross Clamping TimeCardiopulmonary Bypass TimeOperation TimeRe-ThoracotomyICU StayMechanical Ventilation TimeBlood TransfusionNeurological DisorderDialysisAneurysmEndoleakHospital Stay

Keywords

Hyperthermic circulatory arrest; Surgery

Outcome Measures

Primary Outcomes (3)

  • Mortality

    In-hospital Mortality or other related death

    3 months within surgery.

  • Re-thoracotomy

    Postoperative bleeding or other conditions require re-thoracotomy

    Through the hospitalization, an average of 4 weeks.

  • Neurological disorder

    Any neurological event occur after surgery, including transient and permanent.

    Through the hospitalization, an average of 4 weeks.

Secondary Outcomes (11)

  • HCA time

    During the operation

  • Aorta-cross clamp time

    During the operation

  • CPB time

    During the operation

  • Operation time

    During the operation

  • ICU stay

    Through the ICU stay, an average of 1 weeks.

  • +6 more secondary outcomes

Study Arms (2)

Mild hypothermia

EXPERIMENTAL

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

Procedure: the temperature of hypothermic circulatory arrest

Moderate hypothermia

ACTIVE COMPARATOR

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

Procedure: the temperature of hypothermic circulatory arrest

Interventions

the temperature of hypothermic circulatory arrestPROCEDURE

Different temperature (mild 30 degree or moderate 25 degree) employed during the hypothermic circulatory arrest on aortic surgery.

Mild hypothermiaModerate hypothermia

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Nervous System DiseasesAneurysmEndoleak

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Study Officials

  • Xiaoping Fan, PhD

    Guangdong General Hosiptal

    STUDY DIRECTOR

  • Jie He, MD

    Guangdong General Hosiptal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomised controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

February 25, 2018

First Posted

March 6, 2018

Study Start

August 3, 2018

Primary Completion

February 15, 2020

Study Completion

December 15, 2020

Last Updated

August 6, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)