Prospective Investigation of Antithrombin III Deficiency in Adult Patients With ECMO

Extracorporeal Membrane Oxygenation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04879550
• Other study ID #: HNEAH-KAEK 2019/81-866
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: May 2022
• Source: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antithrombin III Deficiency
• Extracorporeal Membrane Oxygenation Complication

Intervention

Diagnostic Test:
• Antithrombin III
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.

Locations

Country	Name	City	State
Turkey	Istanbul Dr.Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antithrombin 3 activity level	Antithrombin 3 activity test levels will be checked in the first 5 days after ecmo application.	5 days
Secondary	Thrombosis and Bleeding Events	Thrombotic or bleeding complications occurring during ECMO run	1 week