Prospective Investigation of Antithrombin III Deficiency in Adult Patients

Status Completed

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.

Clinical Trial 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

Related Conditions & MeSH terms

Antithrombin III Deficiency
Extracorporeal Membrane Oxygenation Complication

Clinical Trial Details

NCT number	NCT04879550
Study type	Observational
Source	Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Contact
Status	Completed
Phase
Start date	January 1, 2020
Completion date	March 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05486559` - The ECMO-Free Trial	N/A
Recruiting	`NCT04674657` - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Not yet recruiting	`NCT05306392` - Effects of Induced Moderate Hypothermia on ARDS Patients Under Venovenous ExtraCorporeal Membrane Oxygenation	N/A
Terminated	`NCT02280460` - ECMO: Optimization of Its Use
Completed	`NCT02271126` - TEG Anticoagulation Monitoring During ECMO	Phase 1
Recruiting	`NCT05444764` - PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS
Completed	`NCT03659513` - The Effect of ECMO on the Pharmacokinetics of the Drugs and Their Clinical Efficacy
Not yet recruiting	`NCT06338345` - Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients	N/A
Completed	`NCT05948332` - Definition and Management of Right Ventricular Injury in Adult Patients Receiving Extracorporeal Membrane Oxygenation
Recruiting	`NCT04273607` - Anticoagulation-free VV ECMO for Acute Respiratory Failure	Phase 2/Phase 3
Not yet recruiting	`NCT04956497` - Registry Study of Extracorporeal Cardiopulmonary Resuscitation (eCPR) in China
Completed	`NCT04052230` - Evolution of Diaphragm Thickness Under Veno-arterial ECMO
Terminated	`NCT04524585` - Partial Neuromuscular Blockade in Acute Respiratory Distress Syndrome	N/A
Completed	`NCT04620005` - Impact of Extra Corporal Membrane Oxygenation Services on Burnout Development in Intensive Care Units.
Recruiting	`NCT05721105` - Evaluation of Long-term Quality of Life in Children Supported With ExtraCorporeal Membrane Oxygenation (ECMO)
Recruiting	`NCT06095518` - DIC Markers and Thrombin Generation Parameters in Patients on ECMO Support: a Pilot Study
Recruiting	`NCT03965208` - Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation	Phase 4
Not yet recruiting	`NCT05814094` - Red Blood Cell Transfusion in ECMO - A Feasibility Trial	N/A
Not yet recruiting	`NCT06319677` - PK/PD Study of Anti-Infective Drugs in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation Treatment
Completed	`NCT05338593` - Therapy and Outcome of Prolonged Veno-venous ECMO Therapy of Critically Ill ARDS Patients.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Prospective Investigation of Antithrombin III Deficiency in Adult Patients With ECMO

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms