Determination and comparison of the efficacy of Reteplase injection versus Heparin injection in patients with dysfunctional Permcath catheters undergoing hemodialysis
Design
A clinical trial with a control group, parallel arms, phase 3, on 63 patients.
Settings and conduct
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, acceptable venous pressure 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. The number of successful hemodialysis sessions will also be recorded during the follow-up period
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient aged 18 years older undergoing hemodialysis via a central venous catheter (CVC) that have become obstructed or dysfunctional
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
Intervention groups
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.
Main outcome variables
Number of effective catheter function days and number of successful hemodialysis sessions after intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260226068952N1
Registration date:2026-03-18, 1404/12/27
Registration timing:prospective
Last update:2026-03-18, 1404/12/27
Update count:0
Registration date
2026-03-18, 1404/12/27
Registrant information
Name
Soroor Abd Emami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
s.abdeemami@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-04-21, 1405/02/01
Expected recruitment end date
2026-08-23, 1405/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effectiveness of Reteplase and Heparin ampoules in patients with permicate catheter dysfunction undergoing hemodialysis
Public title
Studying the effectiveness of Reteplase and Heparin ampoules in patients with permicate catheter dysfunction undergoing hemodialysis
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Sub-1, Mavedat Alley, Shahid Beheshti Blvd.,
City
Qazvin
Province
Qazvin
Postal code
3414443936
Approval date
2026-02-24, 1404/12/05
Ethics committee reference number
IR.QUMS.REC.1404.443
Health conditions studied
1
Description of health condition studied
Dysfunction of Permcath catheter in patients undergoing hemodialysis
ICD-10 code
T82.898
ICD-10 code description
Other specified complication of vascular prosthetic devices, implants and grafts
Primary outcomes
1
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Soroor Abd Emami
Street address
22 Bahman Blvd., Elahieh St., Minoudar Town
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0643
Email
s.abdeemami@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyed Mehdi Mirhashemi
Street address
Sub-1, Mavedat Alley, Shahid Beheshti Blvd.,
City
Qazvin
Province
Qazvin
Postal code
3415613911
Phone
+98 28 3339 7035
Email
research.dpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Soroor Abd Emami
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
22 Bahman Blvd., Elahieh St., Minoudar Town,
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0643
Email
s.abdeemami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Soroor Abd Emami
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
22 Bahman Blvd., Elahieh St., Minoudar Town,
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0643
Email
s.abdeemami@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Soroor Abd Emami
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
22 Bahman Blvd., Elahieh St., Minoudar Town,
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0643
Email
s.abdeemami@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available