Prospective Investigation of Antithrombin III Deficiency in Adult Patients With ECMO

Completed

• Conditions: Extracorporeal Membrane Oxygenation Complication; Antithrombin III Deficiency
• Interventions: Diagnostic Test: Antithrombin III

• Registration Number: NCT04879550
• Lead Sponsor: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

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.

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2021-04-30
• Study First Submitted QC: 2021-05-04
• Study First Posted: 2021-05-10
• Primary Completion: 2022-01-01
• Study Completion: 2022-03-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-22
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Thrombosis and Bleeding Events	1 week	Thrombotic or bleeding complications occurring during ECMO run

Trial Locations

Locations (1)

Istanbul Dr.Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital; 🇹🇷 Istanbul, Turkey