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IRCT201108035625N3 IRCT 2011-08-13 Vice Chancellor for research,Tehran Heart Center (TUMS) Traditional medical treatment versus interventional approach in acute iliofemoral vein thrombosis Comparing the effect of conventional therapy (Heparin followed by warfarin) with imterventional therapy (thrombolysis with or without angioplasty and stenting) on venous patency in patients who admitted with acute iliofemoral DVT in Tehran Heart Center emergency department 2011-08-06 anticipated 30 Complete https://irct.ir/trial/6154 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Acute liofemoral veins thrombosis. Intervention 1: Intervention: lytic therapy will be achieved by placing a catheter in the contralateral femoral vein, the right internal jugular vein, or the ipsilateral popliteal vein for direct intra-clot infusion. An attempt will be made to cross the thrombosed vein with a 0.035-inch guide wire. Once the guide wire crossed the thrombus, multiple side-hole catheters will be advanced into the thrombus to assure maximum delivery of the lytic agent. Streptokinase will be given as a loading dose of 250,000 units followed by infusion of 100,000 units per hour for 24 to 48 hours. Heparin will be administered concomitantly with the lytic therapy and continued until therapeutic anticoagulation with warfarin will be accomplished. aPTT levels will be obtained before and every 12 hours after thrombolytic therapy has been started. Effect of treatment will be assessed daily by venography.Thrombus lysis will be quantified by using thrombus lysis score. Therapy will be continued until maximum lysis will be achieved. After lytic therapy, further intervention (PTA/stenting) will be performed if there is an underlying venous stenosis of 50% or more. Stent placement will be done with appropriate selected stents (self-expanding stainless steel wall stents). All stented patients will be given warfarin indefinitely (INR 2–3). Lysis will be considered complete if there is less than 5% residual thrombus. Intervention 2: Control: conventional treatment will consist of intravenous heparin followed by warfarin. A loading dose of 5,000 to 10,000 units heparin followed by 1,000 to 2,000 units per hour will be given by continuous intravenous infusion. The dose will be adjusted to achieve an activated partial thromboplastin time (aPTT) of twice the control value. Heparin will be given for 5 to 7 days. Warfarin will be initiated within 48 to 72 hours and will be continued as standard guidelines. The warfarin dose will be adjusted to achieve a prothrombin time of 1.5 to 2 times control or an international normalized ratio (INR) of 2 to 3. All patients will be treated with limb elevation and moist heat during their initial admission and maintained on prescription gradient compression stockings.
public Dr.Neda Ghaffari-Marandi
North Kargar and Jalal Al Ahmad cross
Tehran Iran (Islamic Republic of) 1411713138 +98 21 8802 9600 ghaffari_15255@yahoo.com Tehran Heart Center scientific Dr. Yaser Jenab
North Kargar and Jalal Al Ahmad cross
Tehran Iran (Islamic Republic of) 1411713138 +98 21 8802 9600 jenab@razi.tums.ac.ir Tehran Heart Center Iran (Islamic Republic of) Inclusion criteria: Consecutive patients with acute extensive iliofemoral venous thrombosis will be included. Exclusion criteria: previous history of allergy to thrombolytic or contrast agents; anticoagulation contrandications; bleeding disorders, active internal bleeding, recent gastrointestinal bleeding, recent cerebrovascular accident, recent major surgery (<10 days), recent serious trauma, severe hypertension, pregnancy or recent delivery, metastatic malignancy with central nervous system involvement, chronic iliofemoral venous thrombosis (more than 14 days from incidence);patients with survival of less than 1 year; severe renal failure (GFR<30); history of subarachnoid hemorrhage (SAH) or intra cranial hemorrhage (ICH) no limit no limit Both I82 other venous embolism and thrombosis Treatment - Drugs Treatment - Drugs Intervention: lytic therapy will be achieved by placing a catheter in the contralateral femoral vein, the right internal jugular vein, or the ipsilateral popliteal vein for direct intra-clot infusion. An attempt will be made to cross the thrombosed vein with a 0.035-inch guide wire. Once the guide wire crossed the thrombus, multiple side-hole catheters will be advanced into the thrombus to assure maximum delivery of the lytic agent. Streptokinase will be given as a loading dose of 250,000 units followed by infusion of 100,000 units per hour for 24 to 48 hours. Heparin will be administered concomitantly with the lytic therapy and continued until therapeutic anticoagulation with warfarin will be accomplished. aPTT levels will be obtained before and every 12 hours after thrombolytic therapy has been started. Effect of treatment will be assessed daily by venography.Thrombus lysis will be quantified by using thrombus lysis score. Therapy will be continued until maximum lysis will be achieved. After lytic therapy, further intervention (PTA/stenting) will be performed if there is an underlying venous stenosis of 50% or more. Stent placement will be done with appropriate selected stents (self-expanding stainless steel wall stents). All stented patients will be given warfarin indefinitely (INR 2–3). Lysis will be considered complete if there is less than 5% residual thrombus. Control: conventional treatment will consist of intravenous heparin followed by warfarin. A loading dose of 5,000 to 10,000 units heparin followed by 1,000 to 2,000 units per hour will be given by continuous intravenous infusion. The dose will be adjusted to achieve an activated partial thromboplastin time (aPTT) of twice the control value. Heparin will be given for 5 to 7 days. Warfarin will be initiated within 48 to 72 hours and will be continued as standard guidelines. The warfarin dose will be adjusted to achieve a prothrombin time of 1.5 to 2 times control or an international normalized ratio (INR) of 2 to 3. All patients will be treated with limb elevation and moist heat during their initial admission and maintained on prescription gradient compression stockings. Venous patency. Timepoint: One, six and twelve months follow up. Method of measurement: Doppler ultra sonography and MDCT venography. Symptom changes (pain,edema,varices,...). Timepoint: One, six and twelve months follow up. Method of measurement: Clinical evaluation. Vice Chancellor for research,Tehran Heart Center (TUMS) Approved 2011-07-25 Tehran Heart Center ethics committee Tehran Heart Center, North Kargar street and Jalal Al Ahmad cross Tehran Iran (Islamic Republic of)