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Study to Investigate the Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients With Bladder Cancer Undergoing Radical or Total Cystectomy
Basic Trial Information Trial Description Summary Eligibility Criteria Trial Contact Information
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase III
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Supportive care, Treatment
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Active
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18 and over
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Pharmaceutical / Industry
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12002 NCT00306150
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Trial Description
Summary This is a study to investigate the efficacy and safety of aprotinin (Bay a-0128) on transfusion requirements in patients with bladder cancer undergoing radical or total cystectomy. Eligibility Criteria Inclusion Criteria: - Men or non-pregnant women 18 years of age and older
- Patients requiring elective radical or total cystectomy for bladder cancer
- Documented, signed, dated informed consent obtained prior to any study specific procedure being performed
Exclusion Criteria: - Subjects with previous exposure to aprotinin in the last 6 months. If the subject has undergone cardiac surgery in the previous 6 months, all attempts should be made to ascertain if aprotinin was administered during cardiac surgery. If no records are available, or if the subject received aprotinin, the subject should be excluded.
- Subjects with a known or suspected allergy to aprotinin.
- Subjects undergoing laparoscopic resection.
- Patients with symptoms indicative of sepsis or local urinary tract infections that make the patient ineligible for total or radical cystectomy
- Subjects with impaired renal function (serum creatinine > 2.5 mg/dl or 221 micromoles/liter).
- Subjects with a history of bleeding diathesis or known coagulation factor deficiency.
- Subjects with failure of a major organ system or any active significant medical illness that in the opinion of the Investigator is likely to affect the subject’s ability to complete the study or precludes the subject’s participation in the study.
- Subjects who refuse to receive allogenic blood products for religious or other reasons.
- Subjects whose preoperative red blood cell volume is so low that a blood transfusion will have to be given perioperatively (pre-operative hematocrit [Hct] or hemoglobin [Hgb] values < 24% or < 8 g/dl, respectively).
- Subjects whose preoperative red blood cell (RBC) volume is so low that blood will have to be given peri-operatively (Hct or Hgb values < 24% or < 8 g/dl, respectively)
- Subjects with a history of deep vein thrombosis or pulmonary embolism.
- Subjects who are pregnant or women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative pregnancy test and who are not using a reliable method of contraception.
- Planned use of other antifibrinolytic agents eg, aminocaproic acid or tranexamic acid.
- Subjects on a chronic anti-coagulant treatment with vitamin K antagonists where it cannot be discontinued for the surgical procedure.
- Subjects on an investigational drug (i.e. not marketed) in the 30 days prior to screening or during the trial before the 6 week follow-up visit. Subjects involved in trials of marketed cancer therapy medications (including those approved for another indication) or combination with radiotherapy are allowed.
Trial Contact Information
Trial Lead Organizations/Sponsors Bayer Corporation Trial Sites
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U.S.A. |
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Illinois |
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Chicago |
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| | | | | | | | University of Chicago Cancer Research Center |
| | Josephine Silvestre |
Ph: 773-702-3080 |
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Ohio |
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Columbus |
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| | | Columbus Urology, Incorporated |
| | Pam De Tillio |
Ph: 614-457-6028 |
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Email:
pam@columbusurology.com |
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Pennsylvania |
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Pittsburgh |
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| | | UPMC - Shadyside |
| | Rose Lanzo |
Ph: 412-623-6904 |
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Email:
albrrx@anes.upmc.edu |
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Texas |
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Houston |
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| | | M. D. Anderson Cancer Center at University of Texas |
| | Nancy Ainsley |
Ph: 713-563-7474 |
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Email:
nainslie@mdanderson.org |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00306150 Information obtained from ClinicalTrials.gov on 2006-10-27 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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