Morbid ObesityPhase 4NCT02295150
Prophylaxis of Venous Thromboembolism After Bariatric Surgery
A Phase 4 study testing Nadroparin in people with Morbid Obesity and Thromboembolism, run by Rijnstate Hospital at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity, Thromboembolism, Bypass Complications
- What is being tested?
- Nadroparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2013to Jun 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Approval for Roux-en-Y gastric bypass
- Total body weight > 140 kg
Who cannot join
- Renal impairment (GFR < 30ml/min and/ or serum creatinin > 150 micromol/ml)
- Coagulation disorders
- Use of vitamin K antagonists (such as acenocoumarol) pregnancy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Rijnstate Hospital
Arnhem, Wagnerlaan 55, 6800 TA
Wendy Schijns, MD, +31 88 005 888, wschijns@rijnstate.nl
F.J. Berends, MD, PhD
About this study
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.
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.
Read the 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.
- Conditions
- Morbid Obesity, Thromboembolism, Bypass Complications
- Being tested
- Nadroparin
- Keywords
- Nadroparin, Anti-Xa activity
- Medical subject headings
- Obesity, Morbid, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NadroparinDrug
Also called Fraxiparin
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.
| Study group | Role | What they receive |
|---|---|---|
| Nadroparin | Experimental | 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. Receives: Drug: Nadroparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startMar 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frits Berends, Rijnstate Hospital
- Investigators
- F.J. Berends, MD, PhD, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295150
- Sponsor's protocol ID
- Frax001
- Other IDs
- 2012-002816-19
- Status last verified
- Nov 2014
- First submitted
- 11 Nov 2014
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02295150
- Acronym / sponsor ID
- Frax001
- Conditions
- Morbid Obesity, Thromboembolism, Bypass Complications
- Keywords
- Nadroparin, Anti-Xa activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nadroparin | Experimental | Drug: Nadroparinpatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Approval for Roux-en-Y gastric bypass
- Total body weight > 140 kg
Key exclusion criteria (3 listed)
- Renal impairment (GFR < 30ml/min and/ or serum creatinin > 150 micromol/ml)
- Coagulation disorders
- Use of vitamin K antagonists (such as acenocoumarol) pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NadroparinAlso: FraxiparinPatients 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. | Drug | Nadroparin |
Primary outcome
anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
F.J. Berends, MD, PhD principal investigator
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nadroparin in people with Morbid Obesity and Thromboembolism, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wendy Schijns, MD (+31 88 005 8888, wschijns@rijnstate.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2014.