Assess Efficacy and Safety of TachoComb H vs. Standard Surgical Treatment (i.e. Suturing) in Patients Undergoing Prostatectomy (TC-017-AU)

Study Overview
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Brief Summary
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The overall objective is to compare efficacy and safety of TachoComb H versus standard surgical treatment for the control of local bleeding in patients undergoing prostatectomy. Specific objectives include the comparison between test treatments for intraoperative haemostatic efficacy as well as for post-operative blood loss to be assessed by haemoglobin and haematocrit concentration of drainage fluid.

Official Title
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An Open, Randomised, Prospective, Single-centre Phase IV Trial to Assess Efficacy and Safety of TachoComb H Versus Standard Surgical Treatment (i.e. Suture) in Patients Undergoing Prostatectomy

Conditions
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Control of Local Bleeding in Patients Undergoing Prostatectomy.

Intervention / Treatment
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* Drug: Human fibrinogen/thrombin and bovine aprotinin (TachoComb H)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: has the subject given informed consent according to local requirements before any trial related activies? A trial related activity is any procedure that would not have been performed during the routine management of the subject. Is the subject 18 years of age or above ? Is the subject planned for a radical prostatectomy for prostate cancer (cT3)? After prostate resection and primary haemostatic treatment is only minor (i.e. oozing) or moderate haemorrhage persisting after primary surgical haemostatic procedures of the major vessels (no pulsating arterial haemorrhage and/or major venous bleeding)? Exclusion: At pre-operative screen Is there anamnestic or laboratory evidence of coagulation disorders including haemophilia A or B and von Willebrand disease ? Has the patient a history of allergic reactions after application of human fibrinogen, human thrombin, bovine aprotinin and/or collagen of any origin? Is the patient undergoing an emergency operation? Did the patient participate in a clinical trial less than 30 days prior to inclusion in present trial? Does the patient participate in a clinical trial concomitantly with present trial? After tumour resection and primary haemostatic treatment Has any serious surgical complication occurred? Has any fibrin glue haemostatic (including any type of TachoComb) been used before randomisation?

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Human fibrinogen/thrombin and bovine aprotinin (TachoComb H)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Is the percentage of patients/treatment group in which efficient intra-operative haemostasis is achieved within 10 minutes after applying test treatment according to randomisation after primary surgical haemostasis. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: |  |  | 
| Haemoglobin concentration of drainage fluid on day 1 after surgery. |  |  | 
| Haemotocrit concentration of drainage fluid on day 1 after surgery. |  |  | 
| Volume of drainage fluid on day 1 after surgery. |  |  | 
| Incidence of post-operative haematoma at removal site at day 2 after surgery (sonography). |  |  | 
| Incidence of tumour positive resection margin proven by histology (discharge). |  |  | 
| Reporting of occurrence of urinary incontinence (discharge, 3 months +/- 10 days (and optional 12 months +/- 30 days) after surgery. |  |  |