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New treatment option for Cardiopulmonary Bypass
Official title Optimal Cardiopulmonary Bypass and Anticoagulation Management Strategies in Obese Patients Undergoing Cardiac Surgery
ClinicalTrials.gov ID: NCT03302195
What this study is testing
What is Heparin?
Heparin is an investigational medicine, being studied as a potential treatment for cardiopulmonary bypass.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Obese patients (BMI ≥ 30kg/m2)
- Planned cardiac surgery
- Age ≥ 18 years
You likely can't join if
- Permanent pacemaker
- Known intolerance to protamine
- Known or suspected allergy to the used antifibrinolytic agent
- Refusal to receive blood products
- Planned off pump coronary artery bypass
- Planned peri-operative use of desmopressin
See the full eligibility criteria
- Obese patients (BMI ≥ 30kg/m2)
- Planned cardiac surgery
- Age ≥ 18 years
- Permanent pacemaker
- Known intolerance to protamine
- Known or suspected allergy to the used antifibrinolytic agent
- 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
- Known congenital bleeding disorders
- Current endocarditis
- Planned hypothermic circulatory arrest (\<28C)
- Two or more cardiac surgery procedures
- Emergency cardiac surgery procedures (medically required within 24hours of presenting with acute symptoms)
- Planned CPB priming with red blood cells
- Any known autoimmune disease
- Any history of stroke or non-coronary thrombotic disorders including deep venous thrombosis and pulmonary embolism
- Significant (≥50%) carotid artery stenosis
- Patient dosed with low molecular weight Heparin less than 24h before surgery
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
- Confirmed ST elevation myocardial infarction (STEMI) within 7 days
- Pre-operative platelet count \<100,000/microliter
- Anaemia (Hematocrit \<32% for females, \<35%for males)
- 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
- 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)
- Current thromboembolic disease other than myocardial infarct
- Patients who have pre-donated autologous blood
- Patient presenting with a resistance to Heparin
The study team makes the final eligibility decision.
Where it's taking place
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Québec, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.