Related Links Educational Materials About Clinical Trials Clinical Trials: Questions and Answers Questions to Ask Your Doctor Drug Information from MedlinePlus

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care, Treatment Active 18 and over Pharmaceutical / Industry 12002 NCT00306150

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

U.S.A.
Illinois
	Chicago
	University of Chicago Cancer Research Center
		Josephine Silvestre	Ph: 773-702-3080
Ohio
	Columbus
	Columbus Urology, Incorporated
		Pam De Tillio	Ph: 614-457-6028
			Email: pam@columbusurology.com
Pennsylvania
	Pittsburgh
	UPMC - Shadyside
		Rose Lanzo	Ph: 412-623-6904
			Email: albrrx@anes.upmc.edu
Texas
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Nancy Ainsley	Ph: 713-563-7474
			Email: nainslie@mdanderson.org

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00306150
Information obtained from ClinicalTrials.gov on 2006-10-27