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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002816-19 | EudraCT Number |
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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.
There is no guideline for postoperative thromboembolic prevention in morbidly obese patients.
The investigators goal is to examine which dose of nadroparin is effective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nadroparin | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin | 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wendy Schijns, MD | Contact | +31 88 005 8888 | wschijns@rijnstate.nl |
| Name | Affiliation | Role |
|---|---|---|
| F.J. Berends, MD, PhD | Rijnstate Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Recruiting | Arnhem | Wagnerlaan 55 | 6800 TA | Netherlands |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D017762 | Nadroparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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|
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002241 |
| Carbohydrates |