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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Desert Orthopedic Center Medical Research Foundation.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00958945
First Posted: August 14, 2009
Last Update Posted: August 14, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Desert Orthopedic Center Medical Research Foundation
  Purpose
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.

Condition
Total Knee Arthroplasty Arthroplasty, Replacement, Hip

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Retrospective & Prospective Evaluation/Analysis of Hb/Hct in Patients Having Received FloSeal (5ml &10ml) When Undergoing Total Knee or Total Hip Arthroplasty

Further study details as provided by Desert Orthopedic Center Medical Research Foundation:

Estimated Enrollment: 500
Study Start Date: September 2009
Groups/Cohorts
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)

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958945


Contacts
Contact: Charles Z Cyr, BA 760-766-1227 ccyr@desertortho.com

Locations
United States, California
Desert Orthopedic Center
Rancho Mirage, California, United States, 92211
Sponsors and Collaborators
Desert Orthopedic Center Medical Research Foundation
Baxter Healthcare Corporation
Investigators
Principal Investigator: John H. Velyvis,, MD Desert Orthopedic Center
  More Information

Responsible Party: John H. Velyvis, MD, Desert Orthopedic Center Medical Research Foundation
ClinicalTrials.gov Identifier: NCT00958945     History of Changes
Other Study ID Numbers: FloSeal
First Submitted: August 12, 2009
First Posted: August 14, 2009
Last Update Posted: August 14, 2009
Last Verified: August 2009

Keywords provided by Desert Orthopedic Center Medical Research Foundation:
Postoperative Hematocrit
Postoperative Hemoglobin