Fibrin Based Adhesive for the Prevention of Surgical Complications in the Kidney Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Instituto Mexicano del Seguro Social.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Alejandro Gonzalez-Ojeda, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier:
NCT01631448
First received: June 27, 2012
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

Globally there have been about 45,000 kidney transplants last year. Currently, the overall survival of renal transplant receptors is 95% in the first year and 85% at 5 years. A major challenge to overcome by the renal transplant surgeons, are surgical complications which may impact on patient morbidity and mortality, as well as graft function.

The aim of the study is to assess whether application of fibrin seal prevents postoperative complications in patients undergoing kidney transplantation.

Controlled clinical trial with single-blind evaluation in patients surgically intervened kidney transplantation. It will include all patients undergoing renal transplantation in this Medical Center, any gender and over than 16 years and under 60 years.


Condition Intervention Phase
Vascular Postoperative Complications
Urological System Complication of Procedure
Lymphocele
Postoperative Infection
Biological: Fibrin Glue
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Application of the Biological Fibrin Based Adhesive for the Prevention of Surgical Complications in the Kidney Transplant

Resource links provided by NLM:


Further study details as provided by Instituto Mexicano del Seguro Social:

Primary Outcome Measures:
  • Postoperative Complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Patients will be followed from the immediate postoperative period until discharge, and at follow up every week the first month, then every 15 days the second month, and monthly until one year follow up. Identifying any kind of complication derived from the surgical procedure.


Secondary Outcome Measures:
  • Vascular Postoperative Complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    Identifying the different possible vascular postoperative complications:

    • Renal artery stenosis: The narrowing of the light by 30% diagnosed by Doppler ecosonography and corroborated by arteriography.
    • Renal vein stenosis: The narrowing of light> 40% of the renal vein Doppler and confirmed by venography ecosonography graft.
    • Arterial thrombosis: The total occlusion of the renal artery lumen by a thrombus, which prevents blood perfusion of the kidney, diagnosed by Doppler and arteriography of the graft.

  • Urological System Complication of Procedure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    Identifying the different possible urological postoperative complications:

    • Urinary Fistula: The loss of continuity of the ureterovesical anastomosis with formation of a journey outward, allowing the escape of urine into the preperitoneal region at the site of graft placement.
    • Ureteral obstruction: Stopping or reducing the passage of urine into the bladder through the ureter at the ureterovesical anastomosis, which is given by hyperplasia at the site.
    • Ureteral necrosis: devitalization of the ureter as a result of devascularization, with loss of functionality and feasibility.

  • Lymphocele [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    Identifying the different possible lymphatic postoperative complications:

    • Lymphocele: encapsulated collection of lymphatic fluid in postoperative graft site.
    • Lymphatic fistula: Leakage of lymph fluid with formation of a journey to the outside of the surgical wound.

  • Postoperative Infection [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

    Identifying the different possible infectious postoperative complications:

    *Surgical wound infection: Signs of wound infection, like redness, heat, increased local temperature and swelling of the wound. If the drain or treat this is limited, the subcutaneous tissue infection was considered superficial infection of the surgical site, if any collection of pus in the thickness of wound without involvement of the surgical wound abscess be known. If there is necrosis necrotizing myofasciitis be called.



Estimated Enrollment: 152
Study Start Date: May 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Patients fron this group do not receive the fibrin sealant
Active Comparator: Fibrin group
Patients from this group will receive the fibrin sealant
Biological: Fibrin Glue
The biological adhesive will be applied to the study group, with the spray technique in two atmospheres of pressure in a total amount of 10 ml.
Other Name: Tissucol 10 ml (Baxter)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients candidates to renal transplantation

Exclusion Criteria:

  • Patients with known allergy to products of fibrin seal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631448

Contacts
Contact: Alejandro Gonzalez-Ojeda, PhD 523336189538 avygail5@yahoo.com.mx
Contact: Clotilde Fuentes-Orozco, PhD 523336189538 clotildefuen@hotmail.com

Locations
Mexico
Research Unit in Clinical Epidemiology, Specialties Hospital. Mexican Institute of Social Security Recruiting
Guadalajara, Jalisco, Mexico, 44349
Contact: Alejandro Gonzalez-Ojeda, PhD    (52)33 36189538 ext 31384    avygail5@yahoo.com.mx   
Contact: Clotilde Fuentes-Orozco, PhD    (52)33 36189538 ext 31384    clotildefuen@hotmail.com   
Sub-Investigator: Sandoval González-Mercado, MD         
Sub-Investigator: Michel Dassaejv Macías-Amezcua, MD         
Department of Transplantation. Specialties Hospital. Mexican Institute of Sociaql Security Recruiting
Guadalajara, Jalisco, Mexico, 44349
Contact: Joel Sandoval-Sandoval, MD    523336189538 ext 31384    avygail5@yahoo.com.mx   
Sub-Investigator: Carlos Valdespino-Mejía, MD         
Sponsors and Collaborators
Alejandro Gonzalez-Ojeda
Investigators
Study Director: Alejandro Gonzalez-Ojeda, PhD Instituto Mexicano del Seguro Social
  More Information

No publications provided

Responsible Party: Alejandro Gonzalez-Ojeda, PhD, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT01631448     History of Changes
Other Study ID Numbers: Fibrin-2012-01
Study First Received: June 27, 2012
Last Updated: June 28, 2012
Health Authority: Mexico: Ministry of Health

Keywords provided by Instituto Mexicano del Seguro Social:
Fibrin sealant
renal transplantation
surgical complication

Additional relevant MeSH terms:
Lymphocele
Postoperative Complications
Cysts
Neoplasms
Lymphatic Diseases
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014