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.
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2013
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 11, 2014
CompletedFirst Posted
Study publicly available on registry
November 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedNovember 20, 2014
November 1, 2014
2.3 years
November 11, 2014
November 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin
4 hours
Study Arms (1)
Nadroparin
EXPERIMENTALpatients 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.
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.
Eligibility Criteria
You may qualify if:
- Approval for Roux-en-Y gastric bypass
- Total body weight \> 140 kg
You may not qualify if:
- Renal impairment (GFR \< 30ml/min and/ or serum creatinin \> 150 micromol/ml)
- Coagulation disorders
- Use of vitamin K antagonists (such as acenocoumarol) pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rijnstate Hospital
Arnhem, Wagnerlaan 55, 6800 TA, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
F.J. Berends, MD, PhD
Rijnstate Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
November 11, 2014
First Posted
November 20, 2014
Study Start
March 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
November 20, 2014
Record last verified: 2014-11