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Prophylaxis of Venous Thromboembolism After Bariatric Surgery

Sponsor
Rijnstate Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02295150
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
27
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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.
Study Start Date :
Mar 1, 2013
Anticipated Primary Completion Date :
Jun 1, 2015
Anticipated Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.
Other Names:
  • Fraxiparin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin [4 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rijnstate Hospital Arnhem Wagnerlaan 55 Netherlands 6800 TA

    Sponsors and Collaborators

    • Rijnstate Hospital

    Investigators

    • Principal Investigator: F.J. Berends, MD, PhD, Rijnstate Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Frits Berends, Dr., Rijnstate Hospital
    ClinicalTrials.gov Identifier:
    NCT02295150
    Other Study ID Numbers:
    • Frax001
    • 2012-002816-19
    First Posted:
    Nov 20, 2014
    Last Update Posted:
    Nov 20, 2014
    Last Verified:
    Nov 1, 2014
    Keywords provided by Frits Berends, Dr., Rijnstate Hospital
    Nadroparin
    Anti-Xa activity
    Additional relevant MeSH terms:
    Thromboembolism
    Obesity, Morbid
    Nadroparin

    Study Results

    No Results Posted as of Nov 20, 2014