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

NCT01363193 | Unknown

• 1 other identifier: LBW Heparin study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Morbid Obesity; Venous Thromboembolism; Atrial Fibrillation; Angina; Chest Pain

Keywords

Weight-based heparin dosing; Obesity; Body Mass Index; Venous thromboembolism; Atrial fibrillation; Lean body weight; Unfractionated heparin; heparin

Outcome Measures

Primary Outcomes (1)

• Percent of study patients achieving therapeutic aPTT within first 24 hours on a hospital based IV heparin protocol using Lean Body Weight

  24 hours

Secondary Outcomes (1)

• Evaluation of side effects and/or complications during the index hospitalization

  participants will be followed for the duration of hospital stay, usually 7 days or less

Interventions

Lean Body Weight-based heparin dose DRUG

For patients who meet the inclusion criteria including body mass index of 30 and greater (and do not have any exclusion criteria), will have intravenous weight-based heparin (unfractionated heparin) dose based on their Lean body weight. Lean Body Weight is based on the formula by Janmahasatian et al. 2005. Calculated by a computer program; Male = \[9270 x weight (kg)\] / \[6680+216 x BMI\] Female = \[9270 x weight (kg)\] / \[8780+244 x BMI\]

Also known as: unfractionated heparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Nazareth Hospital: lead

Study Sites (1)

Nazareth Hospital - Mercy Health System

Philadelphia, Pennsylvania, 19152, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Venous Thromboembolism; Atrial Fibrillation; Angina Pectoris; Chest Pain

Interventions

Heparin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Myocardial Ischemia; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Rachel J Park, PharmD, BCPS

  Nazareh Hospital - Mercy Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel J Park, PharmD, BCPS

CONTACT

215-335-7703; rpark@mercyhealth.org

Scott B Chelemer, MD, FCCP

CONTACT

215-335-7994; schelemer@mercyhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: June 1, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 14, 2013

Record last verified: 2013-05

Locations

US (1)