N/A
N=66
Heparin Dose and Post Operative Bleeding in Cardiopulmonary Bypass Patients
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01574105 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Chest Tube Losses — 726; 781 millilters — p=<0.1
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Saskatchewan
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chest Tube Losses |
726; 781 | <0.1 |
| SECONDARY Transfusion Events |
4; 16 | — |
Summary
Blood is anticoagulated using a drug named heparin during open-heart surgery to allow it to safely pass through the heart-lung machine which pumps the blood throughout the body during the surgery. Each patient is given the heparin they need for their surgery. This means some patients receive more or less heparin than other patients. In this study, the investigators will be evaluating the current anticoagulation protocol for open heart surgery in use at the Royal University Hospital. The goal of this project is to compare patients who require and receive more heparin for proper anticoagulation to those patients who require and receive less heparin.
Open-heart surgery will proceed according to the standard hospital protocol. All research participants will be treated according to standard post-open heart surgery protocol in the ICU. This will include measurement of blood loss by keeping track of chest tube outputs and administration of blood transfusions.
This study focuses on Saskatoon Health Region patients having open heart surgery in terms of the protocol for anticoagulation and blood transfusions.
Eligibility Criteria
Inclusion Criteria
- Patients scheduled for elective or urgent CABG of two to six vessels.
Exclusion Criteria
- Preoperative:
- Hemoglobin of less than 110grams/Litre
- Under 18 years of age
- Mass less than 75 kilograms
- Presence of an intra-aortic balloon pump
- Emergency surgery, requiring operative intervention within 24 hours of consultation to the cardiac surgery team
- Need for cardiac surgical intervention in addition to planned CABG (with the exception of patent foramen ovale closure)
- Ejection fraction of less than 50%, as determined by echocardiogram or angiography
- Pulmonary hypertension with pulmonary artery pressures greater than 60mmHg
- Presence of infectious endocarditis
- Hepatic failure with impaired liver function, including INR greater than 1.5 Known diagnosed bleeding disorder
- History of heparin induced thrombocytopenia and thrombosis
- Renal failure with pre-operative creatinine greater than 200ml/min or oliguria with urine output less than 10millilitres/hour
- Allergy to tranexamic acid
- Pregnancy
Intraoperative:
- Discovery of infectious endocarditis
- Need for cardiac surgical intervention in addition to planned coronary CABG
Data sourced from ClinicalTrials.gov (NCT01574105). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.