Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-02-27 @ 2:20 PM
Study NCT ID:
NCT02295150
Status:
UNKNOWN
Last Update Posted:
2014-11-20
First Post:
2014-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylaxis of Venous Thromboembolism After Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D013923', 'term': 'Thromboembolism'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017762', 'term': 'Nadroparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-19', 'studyFirstSubmitDate': '2014-11-11', 'studyFirstSubmitQcDate': '2014-11-19', 'lastUpdatePostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anti-Xa activity 4 hours after subcutaneous administration of 5700 IU nadroparin', 'timeFrame': '4 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nadroparin', 'Anti-Xa activity'], 'conditions': ['Morbid Obesity', 'Thromboembolism', 'Bypass Complications']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'There is no guideline for postoperative thromboembolic prevention in morbidly obese patients.\n\nThe investigators goal is to examine which dose of nadroparin is effective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Approval for Roux-en-Y gastric bypass\n* Total body weight \\> 140 kg\n\nExclusion Criteria:\n\n* Renal impairment (GFR \\< 30ml/min and/ or serum creatinin \\> 150 micromol/ml)\n* Coagulation disorders\n* Use of vitamin K antagonists (such as acenocoumarol) pregnancy'}, 'identificationModule': {'nctId': 'NCT02295150', 'briefTitle': 'Prophylaxis of Venous Thromboembolism After Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Rijnstate Hospital'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'Frax001'}, 'secondaryIdInfos': [{'id': '2012-002816-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nadroparin', '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.', 'interventionNames': ['Drug: Nadroparin']}], 'interventions': [{'name': 'Nadroparin', 'type': 'DRUG', 'otherNames': ['Fraxiparin'], '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.', 'armGroupLabels': ['Nadroparin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6800 TA', 'city': 'Arnhem', 'state': 'Wagnerlaan 55', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Wendy Schijns, MD', 'role': 'CONTACT', 'email': 'wschijns@rijnstate.nl', 'phone': '+31 88 005 888'}, {'name': 'F.J. Berends, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rijnstate Hospital', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}], 'centralContacts': [{'name': 'Wendy Schijns, MD', 'role': 'CONTACT', 'email': 'wschijns@rijnstate.nl', 'phone': '+31 88 005 8888'}], 'overallOfficials': [{'name': 'F.J. Berends, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rijnstate Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Frits Berends', 'investigatorAffiliation': 'Rijnstate Hospital'}}}}