Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2011 by Oslo University Hospital.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT01347294

First received: April 11, 2011

Last updated: May 3, 2011

Last verified: April 2011

History of Changes

Purpose

The purpose of this study is to determine the effectiveness of bleomycin, fibrovein and bleomycin and fibrovein in the treatment of venous malformation.

Condition	Intervention	Phase
Venous Malformation	Drug: Bleomycin Drug: Fibrovein Drug: Bleomycin + Fibrovein	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Compare the Effect of Bleomycin and Tetradecyl Sodium Sulphate in the Treatment of Venous Malformations

Resource links provided by NLM:

Drug Information available for: Bleomycin sulfate Bleomycin

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:

Pain [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Pain will be measured before, during and after treatment. It will be asked about type, characteristics and intensity of pain. Using the VAS 0-10 will be used in this matter.


Estimated Enrollment:	126
Study Start Date:	August 2011
Estimated Study Completion Date:	July 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Bleomycin + Fibrovein	Drug: Bleomycin + Fibrovein Intralesional Other Name: Bleomycin Baxter + Fibrovein pharmaceutical products
Active Comparator: Bleomycin	Drug: Bleomycin Intralesional Other Name: Bleomycin Baxter
Experimental: Natrium Tetradecyl Sulphate (Fibrovein )	Drug: Fibrovein Intralesional Other Name: Fibrovein S.T.D pharmaceutical products LTD

Detailed Description:

Patients with scanty symptoms from their vascular malformation can do well with conservative treatment and / or with aids and adaptations in daily life. Compression therapy (elastic stockings), pain medication and good counseling is adequate for many. Patients with significant symptoms, however, may require more invasive treatment. Previously, it was common with surgical removal, but serious sequelae and frequent recurrence after surgery resulted in caution. Today it is more common with intervention radiology treatment with injection of sclerosing agents into existing malformation. This type of therapy almost always requires repeated treatment sequences, sometimes over several months. Treatment aims to seal blood vessels in the malformation and / or make the patient as possible symptoms. Recurrence occurs frequently and there are many who are not completely free from symptoms. Many patients have chronic problems with pain, wounds, bleeding and / or they have a cosmetically disfiguring condition. Predicting the performance of a specific type of treatment can be very difficult.

Until now, there are some studies that have considered the effect of bleomycin / pingyangmycin (China) and ethanol in the treatment of vascular malformations. To our knowledge there is no prospective or retrospective studies that compare the efficacy and side effects of bleomycin and sodium tetradecyl sulfate (Fibrovein ™) in the treatment of VM.

Eligibility


Ages Eligible for Study:	12 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Venous malformation

Exclusion Criteria:

kidney and lung disease

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347294

Contacts


Contact: Tone Meyer, md	+4740281681	tone.meyer@gmail.com
Contact: Rune Andersen, md	+91564775	ruandersen@gmail.com

Locations


Norway
Oslo Universitetssykehus Rikshospitalet	Not yet recruiting
Oslo, Norway, 0227
Contact: Hans Jorgen Smith, phd +4723070000 h.j.smith@medisin.uio.no
Contact: Andreas Abildgaard, phd +4723070000 aabildga@ous-hf.no

Sponsors and Collaborators

Oslo University Hospital

Investigators


Study Director:	Andreas Abildgaard, phd	Oslo Universitetssykehus, Rikshospitalet

More Information

No publications provided


Responsible Party:	Hans Jørgen Smith, Head of Department of Radiology OUS., Department of Radiology, Oslo University Hospital, Norway
ClinicalTrials.gov Identifier:	NCT01347294 History of Changes
Other Study ID Numbers:	1331TMF, TMF1331
Study First Received:	April 11, 2011
Last Updated:	May 3, 2011
Health Authority:	Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:


Congenital Abnormalities Bleomycin Antibiotics, Antineoplastic	Antineoplastic Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 25, 2015

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