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

NCT01631448 | Completed Phase 3 DMC

• 1 other identifier: Fibrin-2012-01
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Vascular Postoperative Complications; Urological System Complication of Procedure; Lymphocele; Postoperative Infection

Keywords

Fibrin sealant; renal transplantation; surgical complication

Outcome Measures

Primary Outcomes (1)

• Postoperative Complications

  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.

  1 year

Secondary Outcomes (4)

• Vascular Postoperative Complications

  1 year

• Urological System Complication of Procedure

  1 year

• Lymphocele

  1 year

• Postoperative Infection

  1 year

Study Arms (2)

Control

NO INTERVENTION

Patients fron this group do not receive the fibrin sealant

Fibrin group

ACTIVE COMPARATOR

Patients from this group will receive the fibrin sealant

Biological: Fibrin Glue

Interventions

Fibrin Glue BIOLOGICAL

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.

Also known as: Tissucol 10 ml (Baxter)

Fibrin group

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients candidates to renal transplantation

You may not qualify if:

• Patients with known allergy to products of fibrin seal

Sponsors & Collaborators

• Alejandro Gonzalez-Ojeda: lead

Study Sites (2)

Department of Transplantation. Specialties Hospital. Mexican Institute of Sociaql Security

Guadalajara, Jalisco, 44349, Mexico

Location

Research Unit in Clinical Epidemiology, Specialties Hospital. Mexican Institute of Social Security

Guadalajara, Jalisco, 44349, Mexico

Location

MeSH Terms

Conditions

Lymphocele

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Alejandro Gonzalez-Ojeda, PhD

  Instituto Mexicano del Seguro Social

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 27, 2012
• First Posted: June 29, 2012
• Study Start: May 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

ME (2)