Prospective Investigation of Antithrombin III Deficiency in Adult Patients With ECMO
NCT ID: NCT04879550
Last Updated: 2022-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2020-01-01
2022-03-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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thrombotic event developing / not
Group I: Patients with no bleeding/thrombosis complications Group II: Patients with Thrombotic and/or thromboembolic complications Group III: Patients with bleeding complications
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Patients with ECMO run for 3 days or more (to be able to determine at least 3 antithrombin 3 levels)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
OTHER
Responsible Party
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Arif Yasin Çakmak
Principal Investigator
Principal Investigators
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Serap AKA
Role: STUDY_DIRECTOR
Cardiovascular Surgeon
Locations
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Istanbul Dr.Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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HNEAH-KAEK 2019/81-866
Identifier Type: -
Identifier Source: org_study_id
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