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OpenTrials
Completed

NCT Number: NCT02633670

Hemopatch Versus No Hemopatch (Renal Transplant)

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.

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Key information

Conditions

Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marylrose Gundayao

Hamilton, Ontario, L8N4A6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

HEMOPATCH

Device

No Hemopatch

Device

Primary outcomes

  1. Blood Loss

    Time frame: Baseline (Intraoperatively)

    Blood loss will be measured in ml (cc).

Secondary outcomes

  1. Hemostasis achievement

    Time frame: Baseline (Intraoperatively)

    Hemostasis achievement will be measured in minutes.

  2. Drop in Hemoglobin

    Time frame: up to 48 hours postoperatively

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

  3. Amount of Perigraft Collection

    Time frame: up to 48 hours postoperative

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

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Registry information

Official study title

A Prospective Randomized Trial of Hemopatch Versus No Hemopatch For the Intraoperative Hemostasis During Deceased Donor Renal Transplant

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 17, 2015
Registry last updated
Dec 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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