Condition category
Haematological Disorders
Date applied
02/07/2012
Date assigned
30/07/2012
Last edited
30/07/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We are carrying out a study of 136 patients who are scheduled for transurethral resection of the prostate (surgical procedure that involves cutting away a section of the prostate gland). During this operation, there is a high risk for bleeding. Therefore, we will test the drug Stibium D6 in order to evaluate its benefit of reduction of bleeding complications. We also test the blood clotting time in 20min intervals during the operation.

Who can participate?
We aim to recruit 136 men, age > 18 years who are scheduled for a transurethral resection of the prostate.

What does the study involve?
Patients will be randomly allocated to receive Stibium D6 intravenous (i.v.) or placebo (dummy). During the operation (under anaesthesia), four blood samples are taken at the beginning of the operation as well as after every 20min. Another blood sample will be taken 1 and 2 days after surgery, respectively. A control examination in our outpatient clinics will be 2 weeks after the operation.

What are the possible benefits and risks of participating?
There could be a direct benefit to those taking part and getting the real drug regarding bleeding complications. If the drug has a beneficial effect on blood clotting, there should be benefits to future patients undergoing transurethral resection of the prostate. Eventually, the drug could be used in surgical interventions other than transurethral resection of the prostate..
The main risk of the intervention is the extra samples of blood that has to be taken. However, the amount of blood is very small. There is no risk for iron deficiency and the related anaemia because of the blood samples. So far, there is no known risk of administering Stibium D6.

Where is the study run from?
The study has been set up by the Urology Department of the University of Bern.

When is study starting and how long is it expected to run for?
It is anticipated that recruitment will start July 2012. Participants will be enrolled on the study for a period of two years.

Who is funding the study?
University Clinic of Urology (Urologische Universitaetsklinik), Switzerland

Who is the main contact?
Dr Beat Roth
urology.berne@insel.ch

Trial website

Contact information

Type

Scientific

Primary contact

Dr Beat Roth

ORCID ID

Contact details

Urologische Universitaetsklinik
Inselspital
Bern
3010
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DR2046

Study information

Scientific title

Double blinded, randomized, placebo-controlled trial to evaluate the efficacy of Stibium D6 on clotting in patients undergoing transurethral resection of the prostate (TURP)

Acronym

Study hypothesis

The anthroposophical drug Stibium D6 has beneficial effect on blood clotting in patients undergoing TURP

Ethics approval

Ethical Committee of the Canton Bern, Switzerland, 03/2012, ref: 235/10

Study design

Randomized double-blinded placebo-controlled single center trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Clotting disorder / intraoperative bleeding / transurethral resection of the prostate

Intervention

Transurethral resection of the prostate in all patients.

50% of patients will receive placebo during this intervention, 50% will receive Stibium D6 intravenous (i.v.).

Stibium D6 -dose: 10ml of 0.000001%, Stibium D6 in 250ml 0.9% NaCl

Total duration of intervention: approximately 1 hour

Intervention type

Drug

Phase

Not Applicable

Drug names

Stibium D6

Primary outcome measures

1. Complications (especially bleeding complications), bleeding complications are measured during the first 14 postoperative days (final evaluation during the final outpatient visit 14 days following surgery)
2. Blood clotting time measured at the beginning of the operation, after 20, 40 and 60 minutes of operation as well as on the 1st and 2nd postoperative day.

Secondary outcome measures

1. Intraoperaperative bleeding score measured during operation
2. Readmissions to hospital evaluated within the first 30 postoperative days
3. Duration of TURP
4. Blood glucose levels measured during operation
5. Duration of catheter in place measured within the first 2 postoperative days (during hospitalisation).
6. Time of postoperative bladder flushing required measured within the first 2 postoperative days (during hospitalisation)

Overall trial start date

01/07/2012

Overall trial end date

30/06/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male
2. >18 years
3. Written informed consent
4. Scheduled for transurethral resection of the prostate

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

136

Participant exclusion criteria

1. Peripheral artery occlusive disease
2. Coronary hart disease
3. Anticoagulation therapy (e.g. cumarines)
4. History of stroke
5. Clotting disorder
6. Allergy / intolerance to Stibium D6

Recruitment start date

01/07/2012

Recruitment end date

30/06/2014

Locations

Countries of recruitment

Switzerland

Trial participating centre

Urologische Universitaetsklinik
Bern
3010
Switzerland

Sponsor information

Organisation

University Clinic of Urology (Urologische Universitaetsklinik) (Switzerland)

Sponsor details

c/o Dr Beat Roth
Inselspital
Bern
3010
Switzerland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Clinic of Urology (Urologische Universitaetsklinik) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes