Prospective Investigation of Antithrombin III Deficiency... | NCT04879550

Studies
Prospective Investigation of Antithrombin III Deficiency in Adult Patients With ECMO

NCT04879550

Sponsor

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Status

Completed

Last Update Posted

May 24, 2022Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Antithrombin III Deficiency
Extracorporeal Membrane Oxygenation Complication

Interventions

Antithrombin III

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Jan 1, 2022Actual

Completion Date

Mar 1, 2022Actual

First Submitted Date

Apr 30, 2021

First Submission Date that Met QC Criteria

May 4, 2021

First Posted Date

May 10, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2022

Last Update Posted Date

May 24, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Arif Yasin Çakmak, Principal Investigator, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research HospitalPrincipal Investigator

Lead Sponsor

Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

There are publications showing a decrease in Antithrombin III levels of continuous flow and routine heparin therapy in adult patients undergoing Extracorporeal Membrane Oxygenation (ECMO) however, there is not enough data. One of the multifactorial causes affecting bleeding / thrombosis complications and ACT levels may be acquired Antithrombin III deficiency.

The Antithrombin III activity test results from the patients to be included in the study during the study will be recorded immediately after ECMO run, at the 24th hour before the heparin infusion start and at the 48th, 72nd and 96th hours following the follow-up. The results will be analyzed to figure out a relationship between decreasing Antithrombin 3 values and thrombotic events.

Detailed Description

ECMO is applied in patients with acute severe heart or lung failure. The treatment protocol of patients undergoing ECMO is carefully arranged against the risk of bleeding / thrombosis.

According to the general protocol, heparin infusion therapy is started at the 24th hour after ECMO application. The risk of bleeding / thrombosis is avoided by adjusting the heparin infusion dose with Activated Clotting Time (ACT) control. However, over time, thrombocytopenia and fluctuations in ACT level are observed in patients. It may be necessary to increase the dose of heparin given during the prolonged period. One of the multifactorial causes affecting bleeding / thrombosis complications and ACT levels may be acquired Antithrombin III deficiency. There are publications reporting a decrease in Antithrombin III levels of continuous flow and routine heparin therapy in adult patients undergoing ECMO; however, there is not enough data.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
thrombotic event developing / not		Group I: Patients with no bleeding/thrombosis complications Group II: Patients with Thrombotic and/or thromboembolic complications Group III: Patients with bleeding complications	Diagnostic Test: Antithrombin III

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antithrombin III	Diagnostic Test	Antithrombin III deficiency causes thrombosis. Is thrombosis in ECMO patients related to Antithrombin III deficiency? Groups with and without thrombosis will be separated and whether it is related to Antithrombin III deficiency will be evaluated.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Antithrombin 3 activity level	Antithrombin 3 activity test levels will be checked in the first 5 days after ecmo application.	5 days

Secondary Outcomes

Measure	Description	Time Frame
Thrombosis and Bleeding Events	Thrombotic or bleeding complications occurring during ECMO run	1 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Being over the age of 18
Patients with ECMO run for 3 days or more (to be able to determine at least 3 antithrombin 3 levels)

Exclusion Criteria:

Patients with ECMO run less than 3 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients over the age of 18 who underwent ECMO in our hospital are our study population.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Serap AKA	Cardiovascular Surgeon	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Dr.Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital		Istanbul		34668	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39207911	Derived	Cakmak AY, Erdogan SB, Sargin M, Er H, Usca MK, Hasbal B, Yapici N, Aka SA. Acquired antithrombin deficiency in adult patients with postcardiotomy extracorporeal membrane oxygenation. Perfusion. 2025 May;40(4):1028-1035. doi: 10.1177/02676591241279764. Epub 2024 Aug 29.

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases