Antithrombin as a Predictor of Heparin Resistance in Cardiac Surgery With Cardiopulmonary Bypass
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSahlgrenska University Hospital
About this trial
This study aims to investigate whether the level of antithrombin (AT) in the blood before cardiac surgery can predict how well patients respond to heparin, a medication used to prevent blood clotting during surgery with a heart-lung machine (cardiopulmonary bypass).
Heparin requires antithrombin to work effectively. Some patients have lower levels of antithrombin, which may result in reduced response to heparin, a condition known as heparin resistance. This can lead to difficulties achieving adequate anticoagulation during surgery and may require additional medication or adjustments in treatment.
In this study, an additional blood sample will be taken after anesthesia induction but before the administration of heparin. No changes will be made to the patient's treatment or care. Clinical data, including laboratory values, heparin dosing, and surgical outcomes, will be collected from routine medical records.
The goal is to identify a clinically useful antithrombin threshold that can help detect patients at risk of heparin resistance. This may improve patient safety, optimize treatment strategies, and reduce unnecessary use of antithrombin therapy in the future.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Planned cardiac surgery with cardiopulmonary bypass
Ability to provide informed consent
Disqualifiers
Emergency cardiac surgery
Ongoing antithrombin supplementation prior to surgery
Known severe congenital coagulation disorder affecting interpretation of outcomes
Severe liver failure
Trial population
Adult patients undergoing elective or sub-acute cardiac surgery with cardiopulmonary bypass at Sahlgrenska University Hospital, Sweden. Patients are consecutively included to reflect routine clinical practice and minimize selection bias.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention (observational study)
Other interventionThis is a prospective observational study. No intervention is assigned as part of the study protocol. All patients receive standard clinical care. A preoperative blood sample is collected for measurement of antithrombin levels, and clinical data are recorded to assess the relationship between antithrombin levels and heparin resistance without influencing treatment.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Patients undergoing cardiac surgery with cardiopulmonary bypass1 intervention
Trial outcomes
Primary outcomes
1
Heparin resistance
Heparin resistance defined as failure to achieve an activated clotting time (ACT) ≥480 seconds after administration of an initial heparin dose of 350 IU/kg, according to standard clinical practice.
Time frame
Intraoperative (immediately after initial heparin administration)Secondary outcomes
1
Activated clotting time after initial heparin dose
Activated clotting time (ACT) measured after administration of the initial heparin dose.
Time frame
Intraoperative (after initial heparin administration)2
Total heparin dose
Total cumulative heparin dose administered until activated clotting time (ACT) ≥480 seconds is achieved.
Time frame
Intraoperative3
Antithrombin supplementation
Administration of antithrombin concentrate due to insufficient anticoagulation.
Time frame
IntraoperativeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: