Renal Failure
Conditions
Brief 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.
Interventions
DEVICEHemopatch
DEVICENo Hemopatch
Sponsors
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Loss | Baseline (Intraoperatively) | Blood loss will be measured in ml (cc). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis achievement | Baseline (Intraoperatively) | Hemostasis achievement will be measured in minutes. |
| Drop in Hemoglobin | up to 48 hours postoperatively | Hemoglobin will be measured in g/L (drop measured from pre-operative levels to post-operative 48 hours). |
| Amount of Perigraft Collection | up to 48 hours postoperative | measured in ml (with ultrasound done within 48 hours of surgery). |
Countries
Canada
Outcome results
None listed