To test whether the anthroposophical drug Stibium D6 has beneficial effect on blood clotting in patients undergoing transurethral resection of the prostate
| ISRCTN | ISRCTN34433361 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34433361 |
| Secondary identifying numbers | DR2046 |
- Submission date
- 02/07/2012
- Registration date
- 30/07/2012
- Last edited
- 30/07/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Plain English summary of protocol
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
Contact information
Scientific
Urologische Universitaetsklinik
Inselspital
Bern
3010
Switzerland
Study information
| Study design | Randomized double-blinded placebo-controlled single center trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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) |
| Study objectives | The anthroposophical drug Stibium D6 has beneficial effect on blood clotting in patients undergoing TURP |
| Ethics approval(s) | Ethical Committee of the Canton Bern, Switzerland, 03/2012, ref: 235/10 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Stibium D6 |
| Primary outcome measure | 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 study start date | 01/07/2012 |
| Completion date | 30/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 136 |
| Key inclusion criteria | 1. Male 2. >18 years 3. Written informed consent 4. Scheduled for transurethral resection of the prostate |
| Key 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 |
| Date of first enrolment | 01/07/2012 |
| Date of final enrolment | 30/06/2014 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
3010
Switzerland
Sponsor information
Hospital/treatment centre
c/o Dr Beat Roth
Inselspital
Bern
3010
Switzerland
"ROR" |
https://ror.org/01q9sj412 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
