Prophylaxis of Venous Thromboembolism After Bariatric Surgery

Morbid Obesity Clinical Trial

Official title:

Prospective, Pharmacokinetic Study for Determination of the Relationship Between Lean Body Weight and Anti-Xa Activity 4 Hours After Subcutaneous Injection of 5700 IU Nadroparin in Morbidly Obese Patients After Bariatric Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02295150
• Other study ID #: Frax001
• Secondary ID: 2012-002816-19
• Status: Recruiting
• Phase: Phase 4
• First received: November 11, 2014
• Last updated: November 19, 2014
• Start date: March 2013
• Est. completion date: June 2015

Study information

• Verified date: November 2014
• Source: Rijnstate Hospital
• Contact: Wendy Schijns, MD
• Phone: +31 88 005 8888
• Email: wschijns[@]rijnstate.nl
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study is a prospective evaluation of the relationship between lean body weight and anti-Xa activity and 5700 International Units (IU) nadroparin 4 hours after subcutaneous administration in morbidly obese patients after bariatric surgery.

Description:

There is no guideline for postoperative thromboembolic prevention in morbidly obese patients.

The investigators goal is to examine which dose of nadroparin is effective.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Approval for Roux-en-Y gastric bypass

• Total body weight > 140 kg

Exclusion Criteria:

• Renal impairment (GFR < 30ml/min and/ or serum creatinin > 150 micromol/ml)

• Coagulation disorders

• Use of vitamin K antagonists (such as acenocoumarol) pregnancy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bypass Complications
• Morbid Obesity
• Obesity, Morbid
• Thromboembolism

Intervention

Drug:
• Nadroparin
Patients receive before surgery 3 days 2850 IU nadroparin. anti-Xa levels will be measured. After surgery they receive 5700 IU for 4 weeks as standard care in our hospital. 3 days and 4 weeks after surgery anti-Xa levels will be measured again.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Wagnerlaan 55

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin		4 hours	No