Prophylaxis of Venous Thromboembolism After Bariatric Surgery

Phase 4

• Conditions: Bypass Complications; Morbid Obesity; Thromboembolism
• Interventions: Drug: Nadroparin

• Registration Number: NCT02295150
• Lead Sponsor: Rijnstate Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-03
• Status Verified: 2014-11
• Study First Submitted: 2014-11-11
• Study First Submitted QC: 2014-11-19
• Last Update Submitted: 2014-11-19
• Study First Posted: 2014-11-20
• Last Update Posted: 2014-11-20
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nadroparin	Nadroparin	patients above 140 kg will receive a dose of 2850 IU nadroparine pre-operatively, anti-Xa factor will be determined 3 days after nadroparin use. After surgery patients receive 5700 IU nadroparin (our standard treatment). Three days after surgery and 4 weeks after surgery anti-Xa factor will be measured again.

Primary Outcome Measures

Name	Time	Method
anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin	4 hours

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Wagnerlaan 55, Netherlands