Prospective Investigation of Antithrombin III Deficiency in Adult Patients With ECMO

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

Status: Completed

Conditions: Antithrombin III Deficiency; Extracorporeal Membrane Oxygenation Complication

Treatments: Diagnostic Test: Antithrombin III

Study type: Observational

Funder types: Other

Identifiers

NCT04879550

HNEAH-KAEK 2019/81-866

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

thrombotic event developing / not

Description:

Group I: Patients with no bleeding/thrombosis complications Group II: Patients with Thrombotic and/or thromboembolic complications Group III: Patients with bleeding complications

Treatment:

Diagnostic Test: Antithrombin III