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Clinical Trials/NCT00958945
NCT00958945
Unknown
Not Applicable

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

Desert Orthopedic Center Medical Research Foundation1 site in 1 country500 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Knee Arthroplasty
Sponsor
Desert Orthopedic Center Medical Research Foundation
Enrollment
500
Locations
1
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
TBD
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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