Assessing the validity of purse-string suturing as an effective modification in TDL placement procedure by comparing incidence of bleeding in patients with and without purse-string suturing
Design
Two arm parallel group randomised trial with outcome assessment without blinding
Settings and conduct
This trial would be conducted at Department of Nephrology, Pak Emirates Military Hospital.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients of either gender aged 18 years or greater, requiring venous access for maintenance hemodialysis.
Exclusion Criteria: Acute kidney injury, bleeding disorders other than uremic platelet dysfunction, blood pressure ≥180/110 mmHg, current use of anticoagulants, platelet count < 50,000/µl, deranged prothrombin time / activated partial thromboplastin time, non-cooperative patient. previous tunneled catheter
insertions at the same site
Intervention groups
Patients in this group would receive a purse string suture approximately one centimeter above the catheter exit site on the upper chest
Main outcome variables
Incidence of bleeding after insertion of tunneled hemodialysis catheter
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250101064242N1
Registration date:2025-01-14, 1403/10/25
Registration timing:retrospective
Last update:2025-01-14, 1403/10/25
Update count:0
Registration date
2025-01-14, 1403/10/25
Registrant information
Name
Obaid Ur Rahman
Name of organization / entity
National University of Medical Sciences Pakistan
Country
Pakistan
Phone
+92 336 5025270
Email address
obaid.96@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-04, 1402/02/14
Expected recruitment end date
2023-10-16, 1402/07/24
Actual recruitment start date
2023-05-04, 1402/02/14
Actual recruitment end date
2023-10-23, 1402/08/01
Trial completion date
empty
Scientific title
Effectiveness of purse string suture in preventing bleeding after insertion of tunneled haemodialysis catheters
Public title
Exit site suture after insertion of tunneled haemodialysis catheters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Requirement of venous access for maintenance hemodialysis.
Exclusion criteria:
Acute kidney injury
blood pressure >180/110 mmHg
current use of anticoagulants
bleeding disorders other than uremic platelet dysfunction
platelet count < 50,000/µl
deranged prothrombin time / activated partial thromboplastin time
non-cooperative patient
previous tunneled catheter insertions at the same site
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
128
Actual sample size reached:
138
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomized in to two groups using online computer generated sequences. These sequences were concealed in opaque envelopes to ensure concealment.
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
Ethical Committee of Pak Emirates Military Hospital
Street address
The Mall Road
City
RAWALPINDI
Postal code
46000
Approval date
2023-04-27, 1402/02/07
Ethics committee reference number
A/28/ERC/200/24
Health conditions studied
1
Description of health condition studied
End stage renal disease
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
Bleeding from exit site
Timepoint
Within 24 hours of catheter insertion
Method of measurement
Reporting to paramedical staff by patients or their caregivers
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All patients in this group would have a purse string suture applied one centimeter from the exit site at the end of the procedure.
Category
Treatment - Surgery
2
Description
Control group: All patients in this group would not have any purse string suture applied at the end of the procedure.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pak Emirates Military Hospital
Full name of responsible person
Obaid-Ur-Rahman
Street address
The Mall Road
City
Rawalpindi
Postal code
46000
Phone
+92 336 5025270
Email
obaid.96@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Sohail Sabir
Street address
The Mall Road
City
Rawalpindi
Postal code
46000
Phone
+92 336 5025270
Email
obaid.96@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pak Emirates Military Hospital
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
Pak Emirates Military Hospital
Full name of responsible person
Obaid Ur Rehman
Position
Registrar
Latest degree
Bachelor
Other areas of specialty/work
Internal Medicine
Street address
The Mall Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 336 5025270
Email
obaid.96@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Obaid Ur Rahman
Position
Registrar
Latest degree
Bachelor
Other areas of specialty/work
Internal Medicine
Street address
The Mall Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 336 5025270
Email
obaid.96@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Obaid Ur Rehman
Position
Registrar
Latest degree
Bachelor
Other areas of specialty/work
Internal Medicine
Street address
The Mall Road
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 336 5025270
Email
obaid.96@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Effectiveness of purse string suture in preventing bleeding after insertion of tunneled haemodialysis catheters
When the data will become available and for how long
For one year after publication of the paper
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Free to use
From where data/document is obtainable
By contacting the first author
What processes are involved for a request to access data/document