Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements

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

Verified August 2009 by Desert Orthopedic Center Medical Research Foundation.
Recruitment status was Not yet recruiting

Sponsor:

Collaborator:

Baxter Healthcare Corporation

Information provided by:

Desert Orthopedic Center Medical Research Foundation

ClinicalTrials.gov Identifier:

NCT00958945

First received: August 12, 2009

Last updated: August 13, 2009

Last verified: August 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

August 12, 2009

Last Updated Date

August 13, 2009

Start Date ^ICMJE

September 2009

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00958945 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements

Official Title ^ICMJE

Retrospective & Prospective Evaluation/Analysis of Hb/Hct in Patients Having Received FloSeal (5ml &10ml) When Undergoing Total Knee or Total Hip Arthroplasty

Brief Summary

The purpose of this analysis is to compare Hemoglobin and Hematocrit levels following total hip or knee arthroplasty. The utilization of FloSeal intraoperatively will improve hemostasis postoperatively. Decreasing bleeding time will decrease the drop in level of Hemoglobin and Hematocrit which usually occurs postoperatively.

Detailed Description

Retrospective Analysis of charts on patients having undergone Total Hip or Total Knee Arthroplasty. During the patient's hospitalization, lab values of Hg and Hct will be recorded for further analysis. Preoperative levels will be also noted to establish baselines.

Primary Data interest will be Hemoglobin (Hgb) level documented during hospitalization along with Hematocrit (HCT) and Red Blood Cell (RBC) data also collected.

Secondary Data gathered will consist of the following:

patient Demographics
Component Profile
Length of Stay
Anesthesia used
Anesthesiologist
EBL
drain type
Amount of drainage fluid recorded at 12 hour increments until discharge
Amount of FloSeal used
Type of Arthroplasty

500 patients in Total
100 Historical Control Patients, knees - no FloSeal (retrospective)
100 Patients, knees - 5mL FloSeal (retrospective)
100 Patients, knees- 10mL FloSeal (prospective)
100 Historical Control patients, hips—no FloSeal (retrospective)
100 retrospective patients, hips—5mL of FloSeal (retrospective

Patients scheduled for Total Knee Arthroplasty will be asked if they wish to participate in the part of the study utilizing 10mL of FloSeal. These patient will be consented and the their data will be retrospectively gathered.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Retrospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

All Dr. Velyvis's patients that have had a Total Knee or Total Hip after January 1, 2007

Condition ^ICMJE

Total Knee Arthroplasty
Arthroplasty, Replacement, Hip

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

FloSeal - Knee - control
100 Historical Control Patients, knees - no FloSeal (retrospective)
FloSeal - Knee - 5ml
100 Patients, knees - 5mL FloSeal (retrospective)
FloSeal - Knee - 10ml
100 Patients, knees- 10mL FloSeal (prospective)
FloSeal - Hip - Control
100 Historical Control patients, hips—no FloSeal (retrospective)
FloSeal - Hip - 5ml
100 retrospective patients, hips—5mL of FloSeal (retrospective)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

500

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Total Knee and Total Hip Patients
Surgical Time less than 2 hours

Exclusion Criteria:

Patients who require greater than 2 hour surgeries
Patients who are undergoing revision arthroplasty
Patients with known allergies to materials of bovine origin

Gender

Both

Ages

18 Years to 95 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Charles Z Cyr, BA

760-766-1227

ccyr@desertortho.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00958945

Other Study ID Numbers ^ICMJE

FloSeal

Has Data Monitoring Committee

Responsible Party

John H. Velyvis, MD, Desert Orthopedic Center Medical Research Foundation

Study Sponsor ^ICMJE

Desert Orthopedic Center Medical Research Foundation

Collaborators ^ICMJE

Baxter Healthcare Corporation

Investigators ^ICMJE

Principal Investigator:

John H. Velyvis,, MD

Desert Orthopedic Center

Information Provided By

Desert Orthopedic Center Medical Research Foundation

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top