Safety and Efficacy of Lean Body Weight-based IV Heparin Dosing in Obese/Morbidly Obese Patients
Safety and Efficacy of Lean Body Weight-based IV Heparin Dosing in Obese/Morbidly Obese Patients
Standard weight-based IV heparin for normal weight patients is based on actual body weight
 (ABW). However, no well-defined guidelines have been established for patients considered to
 be obese or morbidly obese. In current practice, the calculated ABW based heparin initial
 bolus dose and infusion rates are quite high, and therefore often not used for obese/morbidly
 obese patients for fear of bleeding.

 Heparin is distributed in the body approximately the same as blood and does not get
 distributed to adipose tissue. There are some studies suggesting that lean body weight (LBW)
 might be a better basis for dosing heparin. LBW is a calculated weight that excludes the
 weight of fat.

 The investigators hypothesize that intravenous heparin dosing based on the Lean body weight
 of obese/morbidly obese patients would be safe and effective in achieving a therapeutic level
 of heparin in 24 hours compared to the usual practice in this patient population.
Unfractionated Heparin has been used as an anticoagulant in various disease states and
 conditions, such as atrial fibrillation, deep vein thrombosis (DVT), pulmonary embolism (PE),
 myocardial infarction, acute coronary syndrome, and peripheral vascular disease. Prior
 studies have demonstrated that a weight-based heparin (WBH) dosing regimen is superior to a
 fixed dosing regimen (e.g. 5000 units bolus and 1000 units/hour) in achieving a therapeutic
 activated partial thromboplastin time (aPTT) more quickly and with fewer complications (1,2).
 The importance of achieving anticoagulation to a targeted aPTT range within 24 hours after
 starting intravenous heparin infusion has demonstrated a therapeutic benefit (1,3,30-31). WBH
 dosing is now the standard of care for intravenous heparin therapy.

 Prior studies have assessed the benefit of WBH utilizing the patients' actual body weight
 (ABW), but have not significantly considered the issue of dosing and titrating WBH in the
 obese and morbidly obese (O/MO) patient population (1,16-17, 32). There are few studies that
 have examined the effect of obesity in heparin dosing, and there are wide variations in how
 obesity is defined and how (if at all) WBH nomograms based on ABW are adjusted in this
 patient population (4,12,16-18, 23, 25). In addition, there are but a few case reports
 addressing WBH-dosing in the O/MO patient population according to a more modern definition of
 obesity. These limitations make it difficult to apply in the clinical setting (16-18, 21-28).
 In current practice, ABW-based heparin bolus doses and infusion rates are quite high and
 therefore often not used for O/MO patients due to fears of over-anticoagulation and of
 serious bleeding. Studies have in fact reported a higher potential of supratherapeutic aPTT
 in the bariatrically-challenged population (19, 23-24, 26-27). Therefore, it remains
 uncertain as to how to optimize intravenous heparin dosing in these patients.

 The volume of distribution (Vd) of heparin is similar to blood volume and adipose tissue has
 little vasculature to account for heparin's distribution (5-11). LBW has recently been
 proposed to be a better metric for dosing heparin in obese/morbidly obese patients
 (14-15,20,29,34).

 The investigators hypothesize that intravenous heparin (IVH) dosing based on LBW of O/MO
 patients would be safe and effective in achieving aPTT within 24 hours compared to the usual
 practice in this patient population. In addition, the investigators postulate that it would
 be cost-effective since it would reduce the number of blood draws and laboratory tests (13).

 This prospective study will involve the departments of emergency medicine, internal medicine
 (sections of cardiology and critical care), laboratory, nursing, and pharmacy. Those patients
 who are O/MO according to 2004 World Health Organization (WHO) definition (BMI > 30) (33) and
 have an IVH order will be enrolled to receive heparin via a LBW-based nomogram.

 As a comparison, the investigators will also have the calculated initial bolus and infusion
 doses that would have been given in a traditional ABW-based treatment algorithm.

 A signed consent form from the patients will be obtained in order to use the LBW-based
 heparin nomogram. In accordance with the standard weight-based heparin protocol and 2008
 CHEST guidelines, the modified version of current Mercy Nazareth Hospital (MNH) weight-based
 heparin protocol will be followed in all other aspects beyond the dosing nomogram. An aPTT
 tracking form and data collection tool will be utilized to monitor and gather results.

 References on File - provided upon request.
Inclusion Criteria:

 -  Patients with body mass index greater than or equal to 30

 -  Patients admitted to Nazareth Hospital inpatient units

 -  Weight-based intravenous heparin, with a diagnosis of atrial fibrillation, suspected
 or confirmed deep vein thrombosis or pulmonary embolism, unstable angina or Non ST
 elevation myocardial infarction with hemodynamic stability, or peripheral vascular
 disease, ordered at the time of admission/transfer or during the patient stay in the
 Intensive Care unit or Progressive Care unit.

 -  Prior permission from the patient's attending physician

 -  Permission from the physician who ordered the intravenous weight-based heparin (if
 different from the attending)

 -  Signed consent form by the patient.

 Exclusion Criteria:

 -  Patients with stroke, TIA, or ST elevation myocardial infarction

 -  Patients who have hemodynamic or cardiopulmonary instability at the time of
 intravenous heparin order

 -  Patients with thrombophilia

 -  Patients who are pregnant or may be pregnant

 -  Those patients who have been on any oral anticoagulants (Warfarin, rivaroxaban,
 dabigatran or apixaban), treatment dose of other anticoagulants or intravenous
 thrombolytics in previous 7 days.

 -  Patients who have a PTT greater than 37 seconds.

 -  History of heparin-induced thrombocytopenia or known allergy to heparin

 -  Deviation from the Weight-based heparin protocol ordered by a physician at the time
 intravenous heparin was written (i.e. no bolus dose ordered, different target
 therapeutic aPTT range, different bolus dose per kg, etc.)

 -  Informed consent either refused or not obtained

 -  Objection from a physician caring for the patient