Prophylaxis of Venous Thromboembolism After Bariatric Surgery

Rijnstate Hospital

Status and phase: Unknown; Phase 4

Conditions: Bypass Complications; Thromboembolism; Morbid Obesity

Treatments: Drug: Nadroparin

Study type: Interventional

Funder types: Other

Identifiers

NCT02295150

Frax001

2012-002816-19 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Nadroparin

Experimental group

Description:

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.

Treatment:

Drug: Nadroparin