Skip to main content
OpenTrials
Completed

NCT Number: NCT04879550

Prospective Investigation of Antithrombin III Deficiency in Adult Patients With ECMO

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Istanbul, 34668, Turkey (Türkiye)

About this study

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Antithrombin 3 activity level

    Time frame: 5 days

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

Secondary outcomes

  1. Thrombosis and Bleeding Events

    Time frame: 1 week

    Thrombotic or bleeding complications occurring during ECMO run

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Prospective Investigation of the Association of Antithrombin III Deficiency With Thrombotic Events in Adult Patients With ECMO

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 10, 2021
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.