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CompletedNCT02633670Updated Dec 16, 2021

Hemopatch Versus No Hemopatch (Renal Transplant)

An interventional study of Hemopatch and No Hemopatch in Renal Failure, sponsored by St. Joseph's Healthcare Hamilton. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-16.

Sponsored by St. Joseph's Healthcare Hamilton · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

Kidney transplantation remains one of the most common organ transplanted today but the surgical technique has changed very little from the original pelvic operation. The deceased donor renal transplant poses a particular challenge to the surgeon due to lack of detailed pre operative vascular assessment. The hemopatch is a promising new sealing synthetic hemostatIc agent with a novel dual mechanism of action that is more convenient to apply rather then using other hemostatic agents, which require warming and/or mixing.

02

Conditions studied

  • Renal Failure

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03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 20 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

St. Joseph's Healthcare Hamilton is the lead sponsor of 137 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients at least 18 years of age and capable of giving informed consent
  • Patients scheduled for deceased donor renal transplant surgery

Exclusion criteria

Exclusion Criteria:

  • Patient undergoing live related transplant surgery.
  • Patient having uncorrectable bleeding diathesis.
  • Any patient in the no hemopatch group requiring additional haemostatic agents for achieving hemostasis like fibrillar or surgical.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Hemopatch

    The hemopatch is a promising new sealing synthetic hemostatic agent with a noval dual mechanism of action. The hemopatch is a polyethylene glycol coated (PEG coated) collagen patch. The PEG coating helps in rapid adhesion to the tissue surface while the collagen layer causes platelet activation and adhesion.

    Device: Hemopatch

  • Active comparator
    Standard technique

    Standard hemostatic agents (floseal, tisseal).

    Device: No Hemopatch

Interventions

  • DeviceHemopatch
  • DeviceNo Hemopatch
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What researchers measure

Primary outcomes

  1. Blood Loss

    Blood loss will be measured in ml (cc).

    Time frame: Baseline (Intraoperatively)

Secondary outcomes

  1. Hemostasis achievement

    Hemostasis achievement will be measured in minutes.

    Time frame: Baseline (Intraoperatively)

  2. Drop in Hemoglobin

    Hemoglobin will be measured in g/L (drop measured from pre-operative levels to post-operative 48 hours).

    Time frame: up to 48 hours postoperatively

  3. Amount of Perigraft Collection

    measured in ml (with ultrasound done within 48 hours of surgery).

    Time frame: up to 48 hours postoperative

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Study locations

1 site
  • Marylrose Gundayao
    Hamilton, Ontario L8N4A6, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02633670
Lead sponsor
St. Joseph's Healthcare Hamilton
Responsible party
Anil Kapoor (MD, FRCSC, St. Joseph's Healthcare Hamilton) — Principal investigator
First posted
Dec 17, 2015
Start date
Jun 2016
Primary completion
Mar 2020
Completion
Mar 2020
Last update
Dec 16, 2021

Study contacts

Anil Kapoor, MD, FRCSC
principal investigator · McMaster University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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