[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100483026":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":26,"studyPopulation":17,"armGroups":27,"interventions":39,"overallOfficials":51,"centralContacts":65,"locations":76,"responsibleParty":101,"collaborators":17,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":17,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":17,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":79,"whyStopped":17,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Hawler Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Number of participants with VTE events (Deep vein thrombosis or pulmonary embolism)","Deep vein thrombosis or pulmonary embolism will be confirmed by objective methods (Compression duplex ultrasound for deep vein thrombosis; perfusion\u002Fventilation lung for pulmonary embolism )","up to 30 days after surgery",[14],{"measure":15,"description":16,"timeFrame":12},"Side effects of both Bemiparin doses","Major bleedings,minor bleedings ,total bleeding events (major + minor),thrombocytopenia,injection site reactions, serious adverse events,discontinuations due to adverse side effects",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","PARALLEL","Postsurgical morbidly obese patients will be randomized to receive 2 different doses of Bemiparin","PREVENTION",{"masking":24,"maskingDescription":25,"whoMasked":17},"NONE","outcome-assessor blinded study. Due to inherent color differences between the two types of LMWH, the treatment administration could not be fully masked. However, treatment allocation was masked from the outcome assessor from the start by using coded envelopes","Venous thromboembolism (VTE) is serious and preventable in patients who have undergone recent surgery . Most surgical patients are required to receive VTE prophylaxis, usually pharmacologic prophylaxis. Notwithstanding, rates of appropriate perioperative thromboprophylaxis remain tenaciously low, although the expansion of quality-improvement efforts has led to widespread hospital implementation of prophylaxis strategies.\n\nObesity, including morbid obesity, is known to be associated with a high risk of VTE and, unfortunately, fixed doses of anticoagulant regimens (unfractionated heparins, low-molecular-weight heparins, and factor Xa inhibitors) may not provide optimal VTE prophylaxis in these patients especially after surgery. Cumulative evidence and works of the literature suggest that anticoagulant dose adjustments in morbidly obese patients may reduce VTE risk. With the increasing rate of morbid obesity, more high-quality clinical trials are needed to prevent VTE in morbidly obese surgical patients providing effective, safe, prevention strategies.\n\nRationale for Change: Due to challenges in recruiting orthopedic surgical patients within the study timeframe, the protocol has been amended to exclude this patient population. This change ensures the study can proceed with a feasible sample size while maintaining the integrity of the research question regarding LMWH thromboprophylaxis in non-orthopedic surgical patients with morbid obesity. This amendment will not alter the primary research question regarding the efficacy and safety of two doses of LMWH thromboprophylaxis. However, it will narrow the scope of the study to focus exclusively on non-orthopedic surgical patients",[28,34],{"label":29,"type":30,"description":31,"interventionNames":32},"Bemiparin 3500 IU","ACTIVE_COMPARATOR","Bemiparin sodium 3,500 IU anti Xa\u002F0.2 ml solution for injection in the pre-filled syringe will be provided for each patient in one group; subcutaneously 6 hours after the surgery(orthopedic and non-orthopedic) and then daily for up to 10 days for moderate and high - risk group and for 30 days in very high risk-group patients according to Caprinin risk classification for venous thromboembolism.\n\nOther Name: Hibor; Laboratories Rovi Pharmaceuticals",[33],"Drug: Bemiparin 3500",{"label":35,"type":30,"description":36,"interventionNames":37},"Bemiparin 5000 IU","Bemiparin sodium 5000 IU anti Xa\u002F0.2 ml solution for injection in the pre-filled syringe will be provided for each patient in one group; subcutaneously 6 hours after the surgery(orthopedic and non-orthopedic) and then daily for up to 10 days for moderate and high - risk group patients and 30 days in very high-risk group surgical patients according to Caprinin risk classification for venous thromboembolism.\n\nOther Name: Hibor; Laboratories Rovi Pharmaceuticals",[38],"Drug: Bemiparin 5000 IU",[40,46],{"type":41,"name":42,"description":31,"armGroupLabels":43,"otherNames":44},"DRUG","Bemiparin 3500",[29],[45],"Hibor 3500 IU",{"type":41,"name":35,"description":47,"armGroupLabels":48,"otherNames":49},"Bemiparin sodium 5000 IU anti Xa\u002F0.2 ml solution for injection in the pre-filled syringe will be provided for each patient in one group; subcutaneously 6 hours after the surgery(orthopedic and non-orthopedic) and then daily for up to 10 days for moderate and high - risk group and for 30 days in very high risk-group patients according to Caprinin risk classification for venous thromboembolism.\n\nOther Name: Hibor; Laboratories Rovi Pharmaceuticals",[35],[50],"Hibor 5000 IU",[52,55,59,63],{"name":53,"affiliation":5,"role":54},"SHAHLA ALALAF","PRINCIPAL_INVESTIGATOR",{"name":56,"affiliation":57,"role":58},"Ariana Jawad","Kurdistan Higher Counsel of Medical Specialties","STUDY_CHAIR",{"name":60,"affiliation":61,"role":62},"Abdulkader Alany","Hawler Medial University","STUDY_DIRECTOR",{"name":64,"affiliation":5,"role":58},"Ali Al-Dabbagh",[66,72],{"name":67,"role":68,"phone":69,"phoneExt":70,"email":71},"Shahla ALALAF","CONTACT","07504480711","00964","shahla_alaf@yahoo.com",{"name":73,"role":68,"phone":74,"phoneExt":70,"email":75},"Abu bakir Majeed","07504494656","abubakir.majeed@hmu.edu.krd",[77],{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"Hawler Medical university","RECRUITING","Erbil","Kurdistan Region","44001","Iraq","IQ",{"type":86,"coordinates":87},"Point",[88,89],44.00943,36.19117,{"lat":89,"lon":88},[92,97],{"name":93,"role":68,"phone":94,"phoneExt":95,"email":96},"Nazar S. Pauls, PhD","4450611","00964750","nazarpauls@yahoo.com",{"name":98,"role":68,"phone":99,"phoneExt":95,"email":100},"Abubakir S. Majeed, PhD","4494656","info@zjms.org",{"type":54,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"SHAHLA KAREEM ALALAF","Professor","100483026","two-different-regimens-of-bemiparin-as-a-thromboprophylaxis-in-morbidly-obese-surgical-patients-100483026",false,"NCT05569681","Two Different Regimens of Bemiparin as a Thromboprophylaxis in Morbidly Obese Surgical Patients","Comparison of Two Different Regimens of Bemiparin as a Thromboprophylaxis After Surgery in Morbidly Obese Patients: A Randomized, Outcome-assessor Blinded Trial.","Inclusion Criteria:\n\n1. Participants required surgical intervention in: general surgery, gynecology, bariatric surgery\n2. Moderate, high, and very high risk for venous thromboembolism according to Caprin RAM\n3. Participant is willing and able to give informed consent for participation in the study.\n4. BMI ≥40kg\u002Fm2\n\nExclusion Criteria:\n\n1. Having any contraindication to LMWH, such as active bleeding, history of heparin-induced thrombocytopenia , baseline platelet count \\\u003C75 × 108\u002Fμl, severe renal disease (glomerular filtration rate \\\u003C30 ml\u002Fminute), severe liver disease, or uncontrolled hypertension (\\>200\u002F120 mmHg)\n2. Known hypersensitivity to unfractionated or LMWHs\n3. On oral or parenteral anticoagulants within 5 days before surgery\n4. Severe arterial hypertension\n5. Unable to comply with the study treatment and\u002For follow-up\n6. Receiving prohibited medications\n7. Pregnancy or lactation mother",true,"ALL","18 Years","90 Years",{"count":116,"type":117},2400,"ESTIMATED","INTERVENTIONAL",[120],"NA","Morbid obesity, is known to be associated with a high risk of VTE and, unfortunately, fixed doses of anticoagulant regimens may not provide optimal VTE prophylaxis in these patients especially after surgery.",[123],"Morbid Obesity",[125,126,127,128,129,130],"LMWH","Thromboprophylaxis","Non-orthopedic surgeries","Gynecological surgeries","General surgeries","Bariatric surgeries","2026-09-16",{"date":133,"type":134},"2026-09-17","ACTUAL",{"date":136,"type":134},"2023-01-07",{"date":138,"type":117},"2026-10-02",{"name":5,"class":6},1]