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Prophylaxis of Venous Thromboembolism After Bariatric Surgery

Primary Purpose

Morbid Obesity, Thromboembolism, Bypass Complications

Status
Unknown status
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Nadroparin
Sponsored by
Rijnstate Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Morbid Obesity focused on measuring Nadroparin, Anti-Xa activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rijnstate HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nadroparin

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 11, 2014
Last Updated
November 19, 2014
Sponsor
Rijnstate Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02295150
Brief Title
Prophylaxis of Venous Thromboembolism After Bariatric Surgery
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 Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rijnstate Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Thromboembolism, Bypass Complications
Keywords
Nadroparin, Anti-Xa activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nadroparin
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Nadroparin
Other Intervention Name(s)
Fraxiparin
Intervention Description
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.
Primary Outcome Measure Information:
Title
anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy Schijns, MD
Phone
+31 88 005 8888
Email
wschijns@rijnstate.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
F.J. Berends, MD, PhD
Organizational Affiliation
Rijnstate Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
State/Province
Wagnerlaan 55
ZIP/Postal Code
6800 TA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wendy Schijns, MD
Phone
+31 88 005 888
Email
wschijns@rijnstate.nl
First Name & Middle Initial & Last Name & Degree
F.J. Berends, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Prophylaxis of Venous Thromboembolism After Bariatric Surgery

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