Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a prospective, randomized, single blind, standard care- controlled study, which will include a total of 30 patients divided into two treatment arms: First are: patents who will be treated in accordance with standard of care. Second arm: patients for which the Fibrin Fleece will be applied directly on the active bleeding site.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Fibrin Patch Soft Tissue Study

NCT00658723

Hemostasis

COMPLETED PHASE2

Study of Fibrinogen Concentrate (Human) (FCH) to Control Bleeding During Complex Cardiovascular Surgery

NCT01475669

Surgical Blood Loss Postoperative Blood Loss

COMPLETED PHASE3

Safety and Efficacy Study Comparing Pad-gauze With Anti-fibrinolytic Agent Hemostopan™) to a Regular Pad-gauze

NCT01854476

Bleeding Coagulopathy

UNKNOWN PHASE2/PHASE3

TachoComb S Versus Standard Surgical Treatment in Surgical Resection of Renal Tumour (TC-015-IN)

NCT00241163

Surgical Resection of Superficial Renal Tumour

COMPLETED PHASE3

The Severe Soft Tissue Bleeding Study

NCT00977925

Soft Tissue Bleeding

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemostatic Techniques Nephrectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

I

patients who will be treated in accordance with standard of care

Group Type EXPERIMENTAL

Fleece

Intervention Type BIOLOGICAL

Fibrin Patch

II

patients for which the Fibrin Fleece will be applied directly on the active bleeding site.

Group Type ACTIVE_COMPARATOR

Fleece

Intervention Type BIOLOGICAL

Fibrin Patch

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fleece

Fibrin Patch

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients undergoing elective open partial nephrectomy
* Patients must be willing to participate in the study, and provide written informed consent

Exclusion Criteria

* Patients with a tumor diameter greater than 4 cm
* Any additional surgical intervention other than partial nephrectomy
* Patients with only one functional kidney
* Patients with known intolerance to blood products or other components of the product

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No