Prospective Investigation of Antithrombin III Deficiency in Adult Patients With ECMO

NCT04879550 | Completed

• 1 other identifier: HNEAH-KAEK 2019/81-866
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Antithrombin III Deficiency; Extracorporeal Membrane Oxygenation Complication

Keywords

Antithrombin III, ECMO

Outcome Measures

Primary Outcomes (1)

• Antithrombin 3 activity level

  Antithrombin 3 activity test levels will be checked in the first 5 days after ecmo application.

  5 days

Secondary Outcomes (1)

• Thrombosis and Bleeding Events

  1 week

Study Arms (1)

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

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.

thrombotic event developing / not

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• Patients with ECMO run less than 3 days

Sponsors & Collaborators

• Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital: lead

Study Sites (1)

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

Istanbul, 34668, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Antithrombin III activity test

MeSH Terms

Conditions

Antithrombin III Deficiency

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Protein Disorders; Thrombophilia; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Serap AKA

  Cardiovascular Surgeon

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 10, 2021
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)