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Growth of High-Quality Oxides on The Inner Surface of ECMO Circuit by ALD to Reduce Thrombus Formation

Primary Purpose

Anticoagulation

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
ECMO
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anticoagulation focused on measuring Anticoagulation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults
  • Weighing more than 50 kg

Exclusion Criteria:

  • Pregnancy
  • Smoking
  • Chewing betel nut
  • History of any blood or cancer
  • Taking anticoagulants

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ECMO tube

Arm Description

Outcomes

Primary Outcome Measures

Protein content or configuration changed
Use ELISA to measuring the content or configuration of a protein when blood contact material, such as human serum albumin and human plasma fibrinogen etc.

Secondary Outcome Measures

Full Information

First Posted
August 26, 2018
Last Updated
September 5, 2018
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03662594
Brief Title
Growth of High-Quality Oxides on The Inner Surface of ECMO Circuit by ALD to Reduce Thrombus Formation
Official Title
Growth of High-Quality Oxides on The Inner Surface of ECMO Circuit by Atomic Layer Deposition to Reduce Thrombus Formation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 10, 2018 (Actual)
Primary Completion Date
March 20, 2018 (Actual)
Study Completion Date
April 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study evaluate thermal ALD (T-ALD) and plasma-enhance ALD (PE-ALD) processes modified cardiopulmonary bypass (CPB) tubing to investigate anticoagulation properties.
Detailed Description
ECMO is a technique which is currently being used worldwide for providing life support for patients experiencing both pulmonary and cardiac failure. Though ECMO can effectively rescue life at the initial scene, being invasive, complex, resource intensive, and serious related complications developing on the following days of ECMO support have greatly restricted it use. The major causes of ECMO-related mortality and morbidity are serious coagulopathy, either bleeding (7-34%) or thrombosis (8-17%). Contact of high extracorporeal blood flow and the large artificial surfaces plays a critical role leading to the subsequent coagulopathy. Systemic heparin and heparin-bonded circuits is usually used to reduce thrombus. However, non-urgent invasive procedures should be avoided or minimized during that support and regular clinical monitoring to guide the adjustment of optimal dosage is mandatory making the clinical care intensive. Whereas the pharmacological interventions may bring the risk of critical imbalance between hemostasis and thrombosis, efforts to modify the ECMO system focusing on improvement of biocompatibility seem a fundamental way particularly regarding the extended periods of ECMO use. ZrO2 and Al2O3 are more excellent biocompatible and hemocompatible materials compared with PVC (polyvinylchloride) which is the current material of ECMO circuit. Despite the broad applications of ZrO2 and Al2O3 in artificial implants, traditional thin-film coating techniques are unable to deposit these hemocompatible oxides on the inner surface of the PVC tubing in ECMO circuit. In this subproject, the investigators will apply a new technique of atomic layer deposition (ALD) to coat biocompatible and hemocompatible ZrO2/Al2O3 nanolaminate thin films on the inner surface of ECMO tubing to suppress the device-induced coagulopathy. ALD is a thin-film deposition technique for preparing high-quality oxides with atomic-layer accuracy. It offers many benefits including accurate thickness control, excellent conformality, high uniformity, low defect density, good reproducibility, and low deposition temperature. These characteristics clearly accounts for the feasibility to deposit high-quality hemocompatible oxide thin films on the whole surface of complex 3-D structures, such as the inner surface of ECMO tubing, using the ALD technique. The newly-prepared ECMO circuit will then undergo in vitro tests and animal study to carefully examine the safety and effectiveness of improvement of hemocompatibility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anticoagulation
Keywords
Anticoagulation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ECMO tube
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
ECMO
Intervention Description
In this project, the investigators will apply a new technique of atomic layer deposition (ALD) to coat biocompatible and hemocompatible ZrO2/Al2O3 nanolaminate thin films on the inner surface of ECMO tubing to suppress the device-induced coagulopathy. ALD is a thin-film deposition technique for preparing high-quality oxides with atomic-layer accuracy. It offers many benefits including accurate thickness control. These characteristic clear accounts of the high-quality hemocompatible oxide thin films on the whole surface of complex 3-D structures, such as the inner surface The newly-prepared ECMO circuit will then undergo in vitro tests and animal study to carefully examine the safety and effectiveness of improvement of hemocompatibility.
Primary Outcome Measure Information:
Title
Protein content or configuration changed
Description
Use ELISA to measuring the content or configuration of a protein when blood contact material, such as human serum albumin and human plasma fibrinogen etc.
Time Frame
Within 3 days after blood drawed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults Weighing more than 50 kg Exclusion Criteria: Pregnancy Smoking Chewing betel nut History of any blood or cancer Taking anticoagulants
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Growth of High-Quality Oxides on The Inner Surface of ECMO Circuit by ALD to Reduce Thrombus Formation

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