MDACC Study Summary 2007-0921 (Archived)

Study Summary
No. 2007-0921:.......Genitourinary......Christopher Wood......Urology

Study Summary Title



Study Summary Number:	2007-0921

Study Title:	A Prospective, Randomized, Controlled, Superiority Evaluation of Fibrin Patch as an Adjunct to Control Soft Tissue Bleeding During Abdominal, Retroperitoneal, Pelvic, and Thoracic Surgery

Physician

New Patient Referral



Name:	Christopher Wood	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Urology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-3250 Contact us about clinical trials

General Information



Disease Group:	Genitourinary	Supported By:	ETHICON, a Johnson &Johnson Co

Phase of Study:	N/A	Return Visit:	At least 1 month (+14 days) following the procedure, a clinic visit will be performed to assess adverse events and concomitant medications. A blood sample also will be taken at this time. At 8 weeks an additional blood will be required

Treatment Agents:	Fibrin Patch	Home Care:	N/A

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	Patients who undergo cystectomy, radical prostatectomy, simple or radical nephrectomy or adrenalectomy at MD Anderson normally have a hospitalization of 5 - 7 days.


Description/ Intervention:	The goal of this clinical research study is to learn if a drug called Fibrin Patch (FP) can help to control soft tissue bleeding during surgery to remove a tumor in the kidney, adrenal gland, bladder, or prostate. FP will be compared to Surgicel (the device that is considered the standard of care) to see which of these may be better and/or faster at controlling soft tissue bleeding.

Study Objectives / Outcomes

The effectiveness objective of this study is to evaluate whether FP(Fibrin Patch) with manual compression is superior to SURGICEL* with manual compression as an adjunct to achieving hemostasis during surgical procedures involving soft tissue bleeding in abdominal, pelvic, retroperitoneal and (non-cardiac) thoracic surgery.

The primary endpoint will be the proportion of success in achieving hemostasis at 4 minutes after randomization with no re-bleeding requiring treatment during a subsequent 6-minute observation period. Hemostasis is defined as no detectable bleeding at the TBS(Target Bleeding Site).

The secondary endpoints of this study include:
- Proportion of subjects achieving hemostatic success at 10 minutes following randomization (Success at 10 minutes will be defined as the achievement of hemostasis within 10 minutes and no further bleeding requiring treatment during the final 6-minute observation period);
- Incidence of treatment failures (if hemostasis is not achieved within 4 minutes or if bleeding requiring additional intervention during the 6 minute observation period occurs);
- Incidence of adverse events that are potentially related to bleeding at the TBS(Target Bleeding Site).
- Incidence of adverse events that are potentially related to thrombotic events;
- Incidence of adverse events potentially related to transfusion exposure (transfusion related lung injury, multi-organ system failure, transfusion reactions, infectious complications potentially related to transfusion);
- Incidence of re-treatment at the TBS(Target Bleeding Site).;
- Incidence of adverse events.

Study Status Information



Study Activation / Registration Date:	06/10/2008

IRB Review and Approval Date:	02/28/2008

Study Type:	Other

Recruitment Status:	Terminated

Projected Accrual:	Between 90 to 210

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Subjects >/= 18 years of age, requiring non-emergent open abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures;

2) Presence of an appropriate soft tissue TBS(Target Bleeding Site) as identified intra-operatively by the surgeon;

3) Subjects must be willing to participate in the study, and provide written informed consent.

Exclusion Criteria:

1) Subject with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;

2) Subject with TBS (Target Bleeding Site) within an actively infected field

3) Bleeding site is in, around, or in proximity to foramina in bone. or areas of bony confine.

4) Subjects with known intolerance to blood products or one of the components of the study product;

5) Subjects unwilling to receive blood products;

6) Subjects with immunodeficiency disease(including known HIV)

7) Subject who are known, current alcohol and / or drug abuser;

8) Subject who have participated in another investigational drug or device research study within 30 days of enrollment;

9) Female subjects who are pregnant or nursing;

Links

Registration Number: NCT00658723
Study Information on Clinical Trials Registry (clinicaltrials.gov)