Studying the effectiveness of Reteplase and Heparin ampoules in patients with permicate catheter dysfunction undergoing hemodialysis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20260226068952N1

Enrollment

140

Registered

2026-03-18

Start date

2026-04-21

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysfunction of Permcath catheter in patients undergoing hemodialysis. Other specified complication of vascular prosthetic devices, implants and grafts

Interventions

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 norma

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSoroor Abd Emami

Qazvin University of Medical Sciences

s.abdeemami@gmail.com+98 28 3379 0643

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026