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IRCT20260226068952N1 IRCT 2026-03-18 Qazvin University of Medical Sciences Studying the effectiveness of Reteplase and Heparin ampoules in patients with permicate catheter dysfunction undergoing hemodialysis Studying the effectiveness of Reteplase and Heparin ampoules in patients with permicate catheter dysfunction undergoing hemodialysis 2026-04-21 anticipated 140 Recruiting https://irct.ir/trial/89288 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Dysfunction of Permcath catheter in patients undergoing hemodialysis. Intervention 1: Intervention group: Flushing with Reteplase injection at a dose of 1 mg per catheter lumen, administered intraluminally, and retaining the solution for at least 30 minutes before normal saline flushing. Intervention 2: Control group: Flushing with Heparin injection at the standard concentration of 5000 units/ml per catheter lumen, administered intraluminally, and retaining the solution for at least 30 minutes before normal saline flushing. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Participants' dissatisfaction
public Soroor Abd Emami
22 Bahman Blvd., Elahieh St., Minoudar Town,
Qazvin Iran (Islamic Republic of) 3471976161 +98 28 3379 0643 s.abdeemami@gmail.com Qazvin University of Medical Sciences scientific Soroor Abd Emami
22 Bahman Blvd., Elahieh St., Minoudar Town,
Qazvin Iran (Islamic Republic of) 3471976161 +98 28 3379 0643 s.abdeemami@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Patient aged 18 years older undergoing hemodialysis via a central venous catheter (CVC) Implanted Permcath catheters that have become obstructed or dysfunctional Provision of written informed consent to participate in the study 18 years no limit Both Presence of active infection at the catheter site Contraindications to Heparin or Reteplase, such as active bleeding or severe thrombocytopenia Patients requiring catheter removal for reasons other than obstruction such as severe infection or catheter displacement Withdrawal of consent or discontinuation by the patient T82.898 Other specified complication of vascular prosthetic devices, implants and grafts Treatment - Drugs Treatment - Drugs Intervention group: Flushing with Reteplase injection at a dose of 1 mg per catheter lumen, administered intraluminally, and retaining the solution for at least 30 minutes before normal saline flushing. Control group: Flushing with Heparin injection at the standard concentration of 5000 units/ml per catheter lumen, administered intraluminally, and retaining the solution for at least 30 minutes before normal saline flushing. Number of effective catheter function days and number of successful hemodialysis sessions after intervention: After patient allocation into two groups (intervention with rtPA and control with Heparin), the Permcath catheter will be flushed according to the study protocol. Catheter function will be assessed in each hemodialysis session based on adequate blood flow (>200 ml/min), acceptable venous pressure (>250 mmHg) and absence of clinical signs of occlusion. The number of effective catheter function days will be calculated from the day of flushing until recurrent occlusion or the end of follow-up (minimum 3 to 6 months). The number of successful hemodialysis sessions (sessions performed with adequate blood flow and without the need for additional intervention) will also be recorded during the follow-up period. Timepoint: At each hemodialysis session, from the day of intervention until catheter re-occlusion or end of follow-up (3 to 6 months). Method of measurement: All data will be collected and documented by trained nurses and physicians using standardized case report forms. Qazvin University of Medical Sciences Approved 2026-02-24 Ethics committee of Qazvin University of Medical Sciences Sub-1, Mavedat Alley, Shahid Beheshti Blvd., Qazvin Qazvin Iran (Islamic Republic of)