Recruiting

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

Sponsor:

Nazareth Hospital

Code:

NCT01363193

Conditions

Obesity

Morbid Obesity

Venous Thromboembolism

Atrial Fibrillation

Angina

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lean Body Weight-based heparin dose

Study Details

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

Study ID

NCT01363193

Start date

Jul, 2011

Status verified date

May, 2013

Completion date

Dec, 2014

Anticipated

Primary completion date

Dec, 2014

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Lean Body Weight-based heparin dose

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 = \[9270 x weight (kg)\] / \[8780+244 x BMI\]

Primary outcome measure

Percent of study patients achieving therapeutic aPTT within first 24 hours on a hospital based IV heparin protocol using Lean Body Weight [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Rachel J Park, PharmD, BCPS

215-335-7703 rpark@mercyhealth.org

Scott B Chelemer, MD, FCCP

215-335-7994 schelemer@mercyhealth.org

Locations

Nazareth Hospital - Mercy Health System

Recruiting

Philadelphia, Pennsylvania, United States, 19152

Contacts

Rachel J Park, PharmD, BCPS

215-335-7703 rpark@mercyhealth.org

More Information

Sponsor

Nazareth Hospital

Last update posted

May 14, 2013

Last verified

May, 2013

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Nazareth Hospital on 2013-05-14.