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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662594
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE August 26, 2018
First Posted Date  ICMJE September 7, 2018
Last Update Posted Date September 7, 2018
Actual Study Start Date  ICMJE March 10, 2018
Actual Primary Completion Date March 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
Protein content or configuration changed [ Time Frame: Within 3 days after blood drawed ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Growth of High-Quality Oxides on The Inner Surface of ECMO Circuit by ALD to Reduce Thrombus Formation
Official Title  ICMJE Growth of High-Quality Oxides on The Inner Surface of ECMO Circuit by Atomic Layer Deposition to Reduce Thrombus Formation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Anticoagulation
Intervention  ICMJE Other: ECMO
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.
Study Arms  ICMJE ECMO tube
Intervention: Other: ECMO
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2018)
4
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 10, 2018
Actual Primary Completion Date March 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults
  • Weighing more than 50 kg

Exclusion Criteria:

  • Pregnancy
  • Smoking
  • Chewing betel nut
  • History of any blood or cancer
  • Taking anticoagulants
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03662594
Other Study ID Numbers  ICMJE 201801059DINC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Taiwan University Hospital
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP