Comparative Study of Two Brands of Heparin Already on the Market
Condition: Coronary Artery Bypass Grafting
Study type: Interventional

Summary: 
      Two heparin brands have been in the market in Canada for several years. Heparin Leo from Leo
      Pharma and Hepalean from Organon. The former is standardized by B.P (British pharmacopeia)
      while the latter is standardized by U.S.P (United states pharmacopeia). Previous studies have
      shown Heparin Leo to have roughly a 10% less efficacy then Hepalean. It has also been
      demonstrated that more protamine is required to reverse Heparin Leo. It is the investigators'
      intention to study the post-operative effects of the two brands of heparin and whether one of
      the two causes less bleeding after bypass surgery.
    

Detailed description: 
      The study protocol attempts not to change the normal protocol for cardiac surgery too much.

      The two different brands of heparin-Heparin Leo (Leo pharma) and Hepalean (Organon) are
      randomized by the float perfusionist using the program research randomizer.A 50 ml syringe is
      loaded with heparin for the Anesthesiologist and labelled. A 20 ml syringe is loaded with
      heparin and thenn labelled. It is a double blinded trial with the surgeon and anesthetist not
      knowing which brand heparin is being used. All cases are isolated Coronary Artery Bypass
      Grafting (C.A.B.G) with no concomittant conditions. The following are the patients excluded
      from the trial

        1. RE-DO

        2. COMBINATION PROCEDURE

        3. VALVE REPAIR/REPLACEMENT

        4. IABP-PRE/INTRA//POST-OP

        5. CELL SAVER INTRA-OP

        6. ANEMIA (70 g/L)/BLEEDING DISORDER eg:Jehovah's witness,hemophilia etc.

        7. USE OF APROTININ

        8. SMALL ADULT < 50 KG

        9. AORTIC SURGERY WITH/WITHOUT CIRC ARREST

       10. EMERGENT PATIENT WITH HEART FAILURE

      Heparin will be administered in the trial to elevate the A.C.T-Activated clotting time to 480
      s and above and the heparin level to 300u/Kg to intiate cardio-pulmonary bypass (C.P.B).
      Additional heparin will be given to maintain the above-mentioned levels.

      The following data will be studied

        -  BSA

        -  Height

        -  Weight

        -  Diagnosis

        -  Procedure

        -  Surgeon

        -  Anesthetist

        -  Perfusionist

      Pre pump Hb Pump Hb Post pump Hb

      Pre pump ACT Pump ACT Post pump ACT

      Projected heparin conc. Slope Protocol heparin conc Heparin time CPB time X-clamp time
      Heparin (initial dose) Extra heparin on pump Prime Volume RAP Volume Pump balance ml Urine
      output ml Average temp on CPB Phenylephrine Amt Levofed amt Creatinine AST Calculated
      protamine dose at the end of the case Extra protamine given Total protamine CBC after pump
      Total chest tube drainage in OR ml Total patient in OR time

      Pre pump Post Pump Platelet INR PTT PT

      Date Time NA Plavix stopped ASA stopped Heparin stopped Coumadin stopped

      FFP given Total packed cells given Total platelets given Other factors given Other blood
      product given Ca2+ given DDAVP given

      Post-op 6 hrs 12 hrs 24 hrs Chest tube drainage (ml) Chest tube removed time Hct Platelet INR
      PTT

      ADDITIONS Packed cells Cryo Platelets Other blood product / factors

      Chest reopening Yes No The reason if yes Patient transfer date- Time

      Overall we are going to look at whether their is any impact on post-operative
      bleeding,hospital and ICU stay.
    

Intervention name(s): Heparin Leo and Hepalean
Intervention type(s): Drug
Intervention description(s): Dosage based on Heparin does response curve obtained from the Medtronic HMS plus
Other intervention name(s): Heparin Leo; Hepalean
Intervention MeSH terms: Heparin; Calcium heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Heparin Leo; Hepalean; CPB Cardiopuilmonary Bypass; CABG Coronary Artery Bypass Grafting; Anticoagulation efficacy