NCT03302195Recruiting
Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery
Source: ClinicalTrials.gov · Last updated 10 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Standard Heparin management, based on total body weight, is not well established for obese patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). The purpose of this study is to assess the safety and efficacy of using lean body mass (LBM) to determine pump flow rate and/or Heparin dosage in obese patients undergoing CPB.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 410 (estimated)
- First submitted
- 28 Sept 2017
- Start date
- 21 Aug 2015
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Laval University
- Diseases
- Obesity
- NCT number
- NCT03302195
What you commit to
- Study type: Interventional
- Planned participants: 410
- From 21 Aug 2015 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient dosed with low molecular weight Heparin less than 24h before surgery
- Dosed with clopidogrel or ticagrelor within the last 5 days prior to surgery, or prasugrel within 7 days
- Dosed with GPIIb/IIIa receptor blockers (Abciximab, Tirofiban, Eptifibatide) ≤ 24 hours prior to surgery
Other illness
- Known or suspected allergy to the used antifibrinolytic agent
- Known congenital bleeding disorders
- Two or more cardiac surgery procedures
- Emergency cardiac surgery procedures (medically required within 24hours of presenting with acute symptoms)
- Any known autoimmune disease
- Any history of stroke or non-coronary thrombotic disorders including deep venous thrombosis and pulmonary embolism
- Confirmed ST elevation myocardial infarction (STEMI) within 7 days
- Current thromboembolic disease other than myocardial infarct
Lab values
- Pre-operative platelet count \<100,000/microliter
- International ratio (INR) \>1.5 on the day of surgery in patients treated with vitamin K antagonist
- Liver dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) increased ≥ 2-fold above the upper limit of local laboratory normal ranges)
- Renal failure (creatinine ≥ 175 micromol/L or dialysis)
Other
- Permanent pacemaker
- Known intolerance to protamine
- Refusal to receive blood products
- Planned off pump coronary artery bypass
- Planned peri-operative use of desmopressin
- Known Heparin-induced thrombocytopenia
- Known deficiency in protein C, protein S, antithrombin or homozygous factor V Leiden
- Current endocarditis
- Planned hypothermic circulatory arrest (\<28C)
- Planned CPB priming with red blood cells
- Significant (≥50%) carotid artery stenosis
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- Anaemia (Hematocrit \<32% for females, \<35%for males)
- Patients who have pre-donated autologous blood
- Patient presenting with a resistance to Heparin
Who the study is looking for
- Obese patients (BMI ≥ 30kg/m2)
- Planned cardiac surgery
- Age ≥ 18 years
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Laval Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.