Created at Source Raw Value Validated value
Dec. 15, 2020, 2:47 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Patients will be randomized in a 1: 1 ratio between two groups through a digital application.Group 1) Full heparinization with enoxaparin: Full heparinization will be performed with enoxaparin adjusted for creatinine clerance according to the scheme below): 10 patientsCreatinine clearance <75 years> 75 years> 50 ml / min 1 mg / Kg SC BID 0.75 mg / Kg SC BID30-50 ml / min 0.75 mg / Kg BID 1 mg / Kg SC 1x10-30 ml / min 1 mg / kg SC1x 0.75 mg / kg 1x<10 ml / h Will not be included Will not be includedAs renal function can change during the study; we consider daily creatinine dosage necessary and the adjustment of the dose of enoxaparin should be performed daily according to the evolution of renal function. Duration of heparinization: 96 hours. Enoxaparin may be extended up to 7-10 days at the discretion of the medical team for those patients who show significant clinical improvement. Enoxaparin may be suspended at any time if any major or minor bleeding is observed according to the safety criteria included in this study or platelet count below 30;000 mm3. If; during the course; renal function worsens with creatine clearance below 10 ml / min; he should receive unfractionated heparin adjusted by APTT aiming at a ratio between 1.5 and 2.0.Group 2) Prophylactic heparinization: 10 patientsThe control group will receive prophylactic heparin with unfractionated heparin SC at a dose of 5000 IU 8/8 h or enoxaparin 40 mg SC 1 x day. In obese patients (weight> 120 kg); the dose in UFH SC may be increased to 7500 IU SC 8/8 hs and the dose of enoxaparin may be increased to 40 mg SC 12/12 hNote: The full UFH arm was abandoned due to difficulties in adjusting the heparin dose in these patients requiring multiple test collection;Drug;D27.505.954.502.119", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "Full heparinization with enoxaparin", "treatment_id": 463, "treatment_name": "Enoxaparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Prophylactic heparinization with unfractionated heparin or enoxaparin", "treatment_id": 464, "treatment_name": "Enoxaparin or unfractionated heparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]

Oct. 26, 2020, 8:29 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Patients will be randomized in a 1: 1 ratio between two groups through a digital application.Group 1) Full heparinization with enoxaparin: Full heparinization will be performed with enoxaparin adjusted for creatinine clerance according to the scheme below): 10 patientsCreatinine clearance <75 years> 75 years> 50 ml / min 1 mg / Kg SC BID 0.75 mg / Kg SC BID30-50 ml / min 0.75 mg / Kg BID 1 mg / Kg SC 1x10-30 ml / min 1 mg / kg SC1x 0.75 mg / kg 1x<10 ml / h Will not be included Will not be includedAs renal function can change during the study; we consider daily creatinine dosage necessary and the adjustment of the dose of enoxaparin should be performed daily according to the evolution of renal function. Duration of heparinization: 96 hours. Enoxaparin may be extended up to 7-10 days at the discretion of the medical team for those patients who show significant clinical improvement. Enoxaparin may be suspended at any time if any major or minor bleeding is observed according to the safety criteria included in this study or platelet count below 30;000 mm3. If; during the course; renal function worsens with creatine clearance below 10 ml / min; he should receive unfractionated heparin adjusted by APTT aiming at a ratio between 1.5 and 2.0.Group 2) Prophylactic heparinization: 10 patientsThe control group will receive prophylactic heparin with unfractionated heparin SC at a dose of 5000 IU 8/8 h or enoxaparin 40 mg SC 1 x day. In obese patients (weight> 120 kg); the dose in UFH SC may be increased to 7500 IU SC 8/8 hs and the dose of enoxaparin may be increased to 40 mg SC 12/12 hNote: The full UFH arm was abandoned due to difficulties in adjusting the heparin dose in these patients requiring multiple test collection;Drug;Anticoagulants", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]