Clinical trial NCT04879550: Prospective Investigation of Antithrombin III Deficiency in Adult Patients With ECMO
Official title: Prospective Investigation of the Association of Antithrombin III Deficiency With Thrombotic Events in Adult Patients With ECMO
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antithrombin III Deficiency
Extracorporeal Membrane Oxygenation Complication
Keywords: Antithrombin III, ECMO
Lead sponsor: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients over the age of 18 who underwent ECMO in our hospital are our study population.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Antithrombin 3 activity level
timeFrame: 5 days
Secondary outcomes:
measure: Thrombosis and Bleeding Events
timeFrame: 1 week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Dr.Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Study officials:
affiliation: Cardiovascular Surgeon
name: Serap AKA
role: STUDY_DIRECTOR
References: