Heparin Dose and Post Operative Bleeding in Cardiopulmonary Bypass Patients

NCT01574105 | Completed Results

• 1 other identifier: 12-37
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Heparin Dose; Heparin Resistance; Chest Tube Losses; Transfusion Events

Outcome Measures

Primary Outcomes (1)

• Chest Tube Losses

  Chest tube losses will be measured in millilitres upon arrival in the Intensive Care unit (ICU) after six hours in the ICU and total chest tube losses during the ICU stay. Chest tube losses are the amount of blood collected in a graduated chest tube collection reservoir from chest tubes placed in the patient's chest wound at the end of surgery.

  Chest tube losses are recorded from departure from operating room to chest tube removal in the ICU (normally less than 24 hrs)

Secondary Outcomes (1)

• Transfusion Events

  Data collection begins with patient arrival in the operating room and ends with discharge from the ICU (normally less than 24hrs)

Study Arms (2)

Heparin Resistant

Patient whose slope calculated by a heparin dose response test is 89 sec/iu/ml or less.

Heparin Sensitive

Patient whose slope calculated by a heparin dose response test is 90 sec/iu/ml or more.

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

On the date of surgery, the patient would be brought to the operating room. The first blood sample would be drawn prior to heparinization. This would include analysis for Activated Clotting Time, Heparin Concentration/Heparin Dose Response, antithrombin and Thrombelastograph. During this first sampling interval, the patient's Heparin Sensitivity or Resistance is determined by Heparin Dose Response (slope). The following values would determine which one of the two study groups the patient would be assigned: * Sensitive to heparin: at or above 90 seconds/unit/millilitre * Resistant to heparin: below 89 seconds/unit/millilitre

You may qualify if:

• Patients scheduled for elective or urgent CABG of two to six vessels.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (2)

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7S 1E1, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Mark Rosin
• Organization: Saskatoon Health Region

mark.rosin@sasktoonhealthregion.ca

306-655-2128

Study Officials

• Mark W Rosin, MPS

  Saskatoon Health Region

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Perfusionist

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: April 10, 2012
• Study Start: May 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 8, 2014
• Results First Posted: July 8, 2014

Record last verified: 2014-07

Locations

CA (2)