| Conditions: |
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Obesity - Morbid Obesity - Venous Thromboembolism - Atrial Fibrillation - Angina - Chest Pain |
| Purpose: |
|
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.
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| Study Summary: |
|
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.
|
| Criteria: |
|
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
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| NCT ID: |
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NCT01363193 |
| Primary Contact: |
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Principal Investigator
Rachel J Park, PharmD, BCPS
Nazareh Hospital - Mercy Health System
Rachel J Park, PharmD, BCPS
Phone: 215-335-7703
Email: rpark@mercyhealth.org
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| Backup Contact: |
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Email: schelemer@mercyhealth.org
Scott B Chelemer, MD, FCCP
Phone: 215-335-7994
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| Location Contact: |
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Philadelphia, Pennsylvania 19152
United States
Rachel J Park, PharmD, BCPS
Phone: 215-335-7703
Email: rpark@mercyhealth.org
Site Status: Recruiting |