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AnticoagulationNCT03662594

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

A study testing ECMO in people with Anticoagulation, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluate thermal ALD (T-ALD) and plasma-enhance ALD (PE-ALD) processes modified cardiopulmonary bypass (CPB) tubing to investigate anticoagulation properties. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Anticoagulation
What is being tested?
ECMO
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteTaiwan
Study dates
10 Mar 2018to 10 Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults
  • Weighing more than 50 kg

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

About this study

Official title: Growth of High-Quality Oxides on The Inner Surface of ECMO Circuit by Atomic Layer Deposition to Reduce Thrombus Formation

This study evaluate thermal ALD (T-ALD) and plasma-enhance ALD (PE-ALD) processes modified cardiopulmonary bypass (CPB) tubing to investigate anticoagulation properties.

Read the 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.

Conditions
Anticoagulation
Being tested
ECMO
Keywords
Anticoagulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ECMOOther

    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 groups in NCT03662594
Study groupRoleWhat they receive
ECMO tubeOtherNot described
Receives: Other: ECMO

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 3 days after blood drawed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2018
  2. Study start10 Mar 2018
  3. Primary completion20 Mar 2018
  4. Study completion10 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03662594
Sponsor's protocol ID
201801059DINC
Status last verified
Feb 2018
First submitted
26 Aug 2018
Last updated
7 Sep 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing ECMO in people with Anticoagulation, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Protein content or configuration changed (time frame: Within 3 days after blood drawed). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.

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