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IRCT20210614051574N7 IRCT 2022-01-07 Esfahan University of Medical Sciences Autologous blood transfusion with mechanical compression in the treatment of iatrogenic pseudoaneurysm of the femoral artery Comparison of the efficacy and safety of autologous blood injection with c-clamp vascular closure device in treatment of iatrogenic pseudoaneurysm after femoral artery puncture 2022-02-03 anticipated 105 Complete https://irct.ir/trial/61089 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Iatrogenic pseudoaneurysm of the femoral artery. Intervention 1: Intervention group 1: Patients in this group, after diagnosis of femoral artery pseudoaneurysm, under mechanical compression by C-clamp, the pressure of which is marked under the ultrasound guide, and then the amount of pressure applied to the site of the sheath is applied. That homeostasis is established while the distal pulse of the lower limb is palpable. The rate of improvement and treatment complications in patients are evaluated. Intervention 2: Intervention group 2: Patients in this group, after diagnosis of pseudoaneurysm of the femoral artery, 10 to 20 cc of the patient's blood is injected by the same sonographer according to the sonographer's estimate of the sac volume after clot formation under the ultrasound guide in sterile conditions in the pseudoaneurysm sac. The rate of improvement and treatment complications in patients are evaluated. Yes - There is a plan to make this available What will be shared: All data can be shared after people have requested. When: Six months after publishing the results. To whom: Academic researchers Conditions: Scientific uses Where to obtain: Website of the Research Committee of Isfahan University of Medical Sciences How to obtain: Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data. Comments:
public Mohammad Hadi Mansouri
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0042 parsa.alinezhad85@gmail.com Esfahan University of Medical Sciences scientific Mohammad Hadi Mansouri
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0042 parsa.alinezhad85@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with pseudoaneurysm of the femoral artery following angiography Pseudoaneurysm size larger than 2 cm Patient consent to enter the study 18 years 70 years Both Active infection of the groin area Hematoma larger than 2 cm on ultrasound Skin necrosis Symptoms of lower limb ischemia S75.0 Injury of femoral artery Treatment - Devices Treatment - Other Intervention group 1: Patients in this group, after diagnosis of femoral artery pseudoaneurysm, under mechanical compression by C-clamp, the pressure of which is marked under the ultrasound guide, and then the amount of pressure applied to the site of the sheath is applied. That homeostasis is established while the distal pulse of the lower limb is palpable. The rate of improvement and treatment complications in patients are evaluated. Intervention group 2: Patients in this group, after diagnosis of pseudoaneurysm of the femoral artery, 10 to 20 cc of the patient's blood is injected by the same sonographer according to the sonographer's estimate of the sac volume after clot formation under the ultrasound guide in sterile conditions in the pseudoaneurysm sac. The rate of improvement and treatment complications in patients are evaluated. Success of the treatment method in closing pseudoaneurysm. Timepoint: 24 hours and one week after interventions. Method of measurement: By ultrasound. Complications of treatment. Timepoint: 24 hours and one week after interventions. Method of measurement: Examination of patients. Esfahan University of Medical Sciences Approved 2021-02-06 Ethics committee of Esfahan University of Medical Sciences Esfahan University of Medical Sciences, Hezar Jarib Ave., Esfahan Isfahan Isfehan Iran (Islamic Republic of)