To test whether the anthroposophical drug Stibium D6 has beneficial effect on blood clotting in patients undergoing transurethral resection of the prostate

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN34433361

Enrollment

136

Registered

2012-07-30

Start date

2012-07-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clotting disorder / intraoperative bleeding / transurethral resection of the prostate Haematological Disorders

Interventions

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 0.00

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026