Primary objective: prospective evaluation of the relationship between lean body weight and anti-Xa activity of 5700 IU nadroparin 4 hours after subcutaneous administration in morbidly obese patients.Secundary objectives: - Correlation between other…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
antistolling profylaxe bij bariatrische chirurgie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
anti-Xa activity 4 hours after subcutaneous administration of 5700 IU
nadroparin
Secondary outcome
dosage linearity of nadroparin (between 2850 IU and nadrparin 5700 IU)
Background summary
Morbidly obesity is an increasing problem in the Western countries in the last
10 years. Morbidly obese patients have increased risk for venous thrombotic
events (VTE), such as pulmonary embolism (PE) and deep venous thrombosis (VTE).
In addition, bariatric surgery has also increased risk for thromboembolic
complications, with significant risk for morbidity and mortality. Low molecular
heparin as perioperative atithromobotic prophylaxis is common practice,
however, there is a lack of evidence for the dosage of nadroparin. According to
smaller cohort studies, higher prophylactic dosage of nadroparin (5700 IU) is
needed in morbidly obese patients.
Plasma levels of nadroparin, and indirectly the effect of nadroparin, can be
measured by determination of anti-Xa activity. Prophylactic range of anti-Xa
activity is 0.2 - 0.5IU/ml 4 hours after administration of nadroparin. In
non-obese patients 2850 IE nadroparin is an adequate dosage to reach this
range. In morbidly obese patients, these dosage is unknown. Recent study showed
a linear relationship between lean body weight and 5700 IU nadroparin in
morbidly obese patients.
Study objective
Primary objective: prospective evaluation of the relationship between lean body
weight and anti-Xa activity of 5700 IU nadroparin 4 hours after subcutaneous
administration in morbidly obese patients.
Secundary objectives: - Correlation between other body sizes (such as BMI/
total body weight) and renal function (GFR) and anti-Xa activity of 5700 IU
nadroparin 4 hours after subcutaneous administration after bariatric surgery.
- Determination of dosage linearity of anti-Xa activity of nadroparin
Study design
prospective, obeservational (with invasive measurements), pharmacokinetic study
Study burden and risks
Because the obeservational nature of the study, there is no directly benefit
for participation of the study. The aim of the study is to optimilize
perioperative antithrombotic profylaxis after bariatric surgery in morbidly
obese patients. Extraprotocolar, the participants will be administered for 3
days nadroparine 2850 IU. Because this short term, the risks are negligible.
Wagnerlaan 55
6800 TA Arnhem
NL
Wagnerlaan 55
6800 TA Arnhem
NL
Listed location countries
Age
Inclusion criteria
approval for Roux-en-Y gastric bypass
body weight of > 140 kg
Exclusion criteria
renal impairment (GFR < 30 and/or serum creatinin > 150)
Anticoagulation disorders (PT/APT > 2x norm)
Use of oral anticoagulation (such as acenocoumarol)
pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-002816-19-NL |
| CCMO | NL41144.091.12 |