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Prophylaxis of Venous Thromboembolism After Bariatric Surgery

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.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02295150
Enrollment
50
Registered
2014-11-20
Start date
2013-03-31
Completion date
2015-06-30
Last updated
2014-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity, Thromboembolism, Bypass Complications

Keywords

Nadroparin, Anti-Xa activity

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.

Interventions

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.

Sponsors

Rijnstate Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin4 hours

Countries

Netherlands

Contacts

Primary ContactWendy Schijns, MD
wschijns@rijnstate.nl+31 88 005 8888

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026