Antithrombin III DeficiencyNCT04879550
Prospective Investigation of Antithrombin III Deficiency in Adult Patients With ECMO
An observational study of Antithrombin III Deficiency and Extracorporeal Membrane Oxygenation Complication, run by Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antithrombin III Deficiency, Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- Antithrombin III
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients over the age of 18 who underwent ECMO in our hospital are our study population.
Who may be able to join
- 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)
Who cannot join
- Patients with ECMO run less than 3 days
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Dr.Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Istanbul, 34668
About this study
Official title: Prospective Investigation of the Association of Antithrombin III Deficiency With Thrombotic Events in Adult Patients With ECMO
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.
Read the 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.
- Being tested
- Antithrombin III
- Keywords
- Antithrombin III, ECMO
- Medical subject headings
- Antithrombin III Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antithrombin IIIDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Antithrombin III |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antithrombin 3 activity level
Antithrombin 3 activity test levels will be checked in the first 5 days after ecmo application.
Measured: 5 days
Secondary outcomes (1)
Thrombosis and Bleeding Events
Thrombotic or bleeding complications occurring during ECMO run
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start1 Jan 2020
- Primary completion1 Jan 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antithrombin III DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arif Yasin Çakmak, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
- Investigators
- Serap AKA, Study director, Cardiovascular Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879550
- Sponsor's protocol ID
- HNEAH-KAEK 2019/81-866
- Status last verified
- May 2022
- First submitted
- 30 Apr 2021
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cakmak AY, Erdogan SB, Sargin M, Er H, Usca MK, Hasbal B, Yapici N, Aka SA. Acquired antithrombin deficiency in adult patients with postcardiotomy extracorporeal membrane oxygenation. Perfusion. 2025 May;40(4):1028-1035. doi: 10.1177/02676591241279764. Epub 2024 Aug 29.
PubMed 39207911
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Investigation of the Association of Antithrombin III Deficiency With Thrombotic Events in Adult Patients With ECMO
- ClinicalTrials.gov ID
- NCT04879550
- Acronym / sponsor ID
- HNEAH-KAEK 2019/81-866
- Keywords
- Antithrombin III, ECMO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thrombotic event developing / not | – | Diagnostic Test: Antithrombin IIIGroup I: Patients with no bleeding/thrombosis complications Group II: Patients with Thrombotic and/or thromboembolic complications Group III: Patients with bleeding complications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients over the age of 18 who underwent ECMO in our hospital are our study population.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Patients with ECMO run less than 3 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antithrombin IIIAntithrombin 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. | Diagnostic test | thrombotic event developing / not |
Primary outcome
Antithrombin 3 activity level
Time frame: 5 days
Antithrombin 3 activity test levels will be checked in the first 5 days after ecmo application.
1 secondary outcome
Thrombosis and Bleeding Events
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Derived from this study: PubMed 39207911Cakmak AY, Erdogan SB, Sargin M, Er H, Usca MK, Hasbal B, Yapici N, Aka SA. Acquired antithrombin deficiency in adult patients with postcardiotomy extracorporeal membrane oxygenation. Perfusion. 2025 May;40(4):1028-1035. doi: 10.1177/02676591241279764. Epub 2024 Aug 29.
- Individual participant dataSharing planned: No
Related trials for Antithrombin III Deficiency
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Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
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Belgian Antithrombin Deficiency Registry
Antithrombin III Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serap AKA study director
Cardiovascular Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antithrombin III Deficiency and Extracorporeal Membrane Oxygenation Complication, run by Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antithrombin 3 activity level (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04879550, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.