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Heparin Pharmacokinetics in Response to Temperature Variation during Cardiopulmonary Bypass

A prospective, observational study of the effects of therapeutic variable hypothermia on heparin metabolism in adult patients undergoing cardiac surgery on cardiopulmonary bypass

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621001270808
Acronym
HepTemp
Enrollment
40
Registered
2021-09-20
Start date
2021-10-01
Completion date
2022-03-01
Last updated
2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

HepTemp is a prospective observational study of heparin pharmacokinetics whereby the effect of therapeutic hypothermia on heparin clearance will be observed at different temperatures in individual patients and compared with the equivalent rate of clearance when the same patient is returned to normothermia at the end of cardiopulmonary bypass, prior to separation. Mathematical modelling to demonstrate the changes in elimination time constant with differing temperatures will be derived to allow correction of existing mathematical models of heparin elimination.

Interventions

Most patients undergoing cardiac surgery will require a heart-lung machine, or cardiopulmonary bypass (CPB). This is to allow the heart to be temporarily stopped during surgery to allow the surgeon to operate on a still, bloodless field. The heart-lung machine allows blood to circulate in the body during this time, keep the body supplied with oxygen and for carbon dioxide to be removed. During CPB, patients are often cooled to protect the organs. The 'target temperature' for cooling ranges bet

Most patients undergoing cardiac surgery will require a heart-lung machine, or cardiopulmonary bypass (CPB). This is to allow the heart to be temporarily stopped during surgery to allow the surgeon to operate on a still, bloodless field. The heart-lung machine allows blood to circulate in the body during this time, keep the body supplied with oxygen and for carbon dioxide to be removed. During CPB, patients are often cooled to protect the organs. The 'target temperature' for cooling ranges between 28 and 34°C depending on the type of surgery and the surgeon preference. The duration of cooling and the duration of CPB are determined by the operation, not the study protocol. Patients will spend the same amount of time on CPB and cooled during their surgery regardless of whether they participate in the study. All patients receive a dose of heparin to stop blood clotting in the heart-lung machine during surgery. For this study, patients will receive 400 IU/kg based on ideal body weight. They will then be cooled to the target temperature during CPB. Once the target temperature is reached as measured by a catheter in the bladder, a further dose of 100 IU/kg based on ideal body weight will be administered, and a series of blood samples (2 mL every 6 minutes for 30 minutes) will be taken to measure heparin levels. The dose of heparin will not be altered by changes in clearance, although if the measured activated clotting time (ACT) falls below 450 seconds, a further dose of 100 IU/kg of heparin can be administered.

Sponsors

Department of Anaesthesia, Austin Health
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patient undergoing cardiac surgery requiring cardiopulmonary bypass

Exclusion criteria

Administration of therapeutic low molecular weight heparin or unfractionated heparin infusion < 24 hours prior to planned cardiac surgery End-stage renal failure or anticipated requirement for haemofiltration on cardiopulmonary bypass Anticipated duration of cardiopulmonary bypass < 60 minutes Plan for intra-operative cooling below 25°C BMI > 30 kg/m² Patients unable to give informed consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026