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

NCT03662594 | Completed

• 1 other identifier: 201801059DINC
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Anticoagulation

Keywords

Anticoagulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 3 days after blood drawed

Study Arms (1)

ECMO tube

OTHER

Other: ECMO

Interventions

ECMO OTHER

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.

ECMO tube

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults
• Weighing more than 50 kg

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2018
• First Posted: September 7, 2018
• Study Start: March 10, 2018
• Primary Completion: March 20, 2018
• Study Completion: April 10, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-02

Locations

TW (1)