Skip to main content
OpenTrials
Completed

NCT Number: NCT01235715

The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery

Application of "Evicel" hemostatic matrix during operation for unilateral total knee replacement surgery (TKA) will result in decreased bleeding and postoperative drain output, a reduction in transfusion requirements, and less reduction of hemoglobin.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

About this study

No additional data desired

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of degenerative joint disease of the knee in patients medically suitable to undergo unilateral total knee arthroplasty

Exclusion criteria

  • Known allergies to human blood products.
  • History of bleeding disorders.
  • Patients with previous arthrotomy, however, with exception of medial or lateral menisectomy.
  • Patients taking Lovenox, Plavix, Aggrenox or erythropoetin. (coumadin is acceptable)
  • Additionally, any patient with an intra-operative complication (i.e bone fracture, vascular injury) or post-operative complication that would affect bleeding tendency will be excluded although data will be recorded for later analysis. Also, any patient who has a complication with the suction drain (eg inadvertently being pulled out, suction failing) will have the remaining data points recorded and drain measurements will be excluded from analysis.

Treatment and study plan

Evicel fibrin sealant

Drug

Used for hemostasis to control bleeding. It has been shown to stop bleeding in 2 minutes or less. It is a combination of a biologic activated component containing human fibrinogen and topical thrombin functioning on wet, actively bleeding tissue.

Primary outcomes

  1. Change in Hemoglobin on Day 0 Compared to Preoperatively

    Time frame: preoperatively and on the day of surgery

  2. Change in Hematocrit on Day 0 Compared to Preoperatively

    Time frame: preoperatively and day of surgery

  3. Change in Hemoglobin On Day 1 Compared to Preoperatively

    Time frame: preoperatively and one day after surgery

  4. Change in Hematocrit on Day 1 Compared to Preoperatively

    Time frame: preoperatively and one day after surgery

  5. Change in Hemoglobin on Day 2 Compared to Preoperatively

    Time frame: preoperatively and two days after surgery

  6. Change in Hematocrit on Day 2 Compared to Preoperatively

    Time frame: preoperatively and two days after surgery

  7. Drain Output

    Time frame: 24 hours post-operatively

    A measurement of the amount of blood drained from the knee.

  8. Number of Autologous Transfusion Units Over the Course of the Hospital Stay

    Time frame: perioperatively

    Units of autologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.

  9. Units of Homologous Transfusion Over the Course of the Hospital Stay

    Time frame: three days postoperatively

    Units of homologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.

Secondary outcomes

  1. Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively

    Time frame: preoperatively and two days after surgery

    The INR, a measure of the clotting tendency of blood, is a ratio of a patient's prothrombin time (the time a blood plasma takes to clot after the addition of tissue factor) to a normal prothrombin time.

  2. Range of Motion on Day 3

    Time frame: 3 days postoperatively

    A measurement of the degrees of motion of the operated knee three days after surgery.

  3. Visual Analog Pain Scale on Day 3

    Time frame: 3 days postoperatively

    The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale.

  4. Range of Motion at 6 Weeks

    Time frame: 6 weeks postoperatively

    A measurement of the degrees of motion of the operated knee six weeks after surgery.

  5. Visual Analog Pain Scale (at Rest) at 6 Weeks

    Time frame: 6 weeks postoperatively

    The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at rest, the patient indicates their level of pain while seated or lying down, not moving.

  6. Visual Analog Pain Scale (During Activity) at 6 Weeks

    Time frame: 6 weeks postoperatively

    The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain while doing activities of daily living such as walking and moving from sitting to standing.

  7. Visual Analog Pain Scale (During Therapy) at 6 Weeks

    Time frame: 6 weeks postoperatively

    The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain during, the patient indicates their level of pain during physical therapy.

  8. Visual Analog Pain Scale (At Night) At 6 Weeks

    Time frame: 6 weeks postoperatively

    The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. Drawings of faces indicate the level of pain associated with different points on the scale. For the measure of pain at night, the patient indicates their level of pain during or before sleep.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Collaborators

  • Ethicon, Inc.

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 5, 2010
Registry last updated
Oct 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.