Prophylaxis of Venous Thromboembolism After Bariatric Surgery

NCT ID: NCT02295150

Last Updated: 2014-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-06-30

Brief Summary

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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

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

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

Conditions

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Morbid Obesity Thromboembolism Bypass Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Nadroparin

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Fraxiparin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rijnstate Hospital

OTHER

Sponsor Role lead

Responsible Party

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Frits Berends

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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F.J. Berends, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rijnstate Hospital

Locations

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Rijnstate Hospital

Arnhem, Wagnerlaan 55, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Wendy Schijns, MD

Role: CONTACT

+31 88 005 8888

Facility Contacts

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Wendy Schijns, MD

Role: primary

+31 88 005 888

Other Identifiers

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2012-002816-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Frax001

Identifier Type: -

Identifier Source: org_study_id