Safety and Efficacy of Lean Body Weight-based IV Heparin Dosing in Obese/Morbidly Obese Patients

Status unconfirmed · Not applicable

Conditions studied: Obesity, Morbid Obesity, Venous Thromboembolism, Atrial Fibrillation, Angina, Chest Pain

In brief

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.

Key facts

Study ID

NCT01363193

Run by

Nazareth Hospital

People needed

100

Starts

2011-07-01

Expected to finish

2014-12-01

Last updated by the study team

2013-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Nazareth Hospital - Mercy Health System — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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