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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01235715

Enrollment

200

Registered

2010-11-05

Start date

2010-09-30

Completion date

2012-09-30

Last updated

2013-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

osteoarthritis, total knee replacement

Brief summary

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.

Detailed description

No additional data desired

Interventions

DRUGEvicel fibrin sealant

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Units of Homologous Transfusion Over the Course of the Hospital Stay	three days postoperatively	Units of homologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.
Change in Hemoglobin on Day 0 Compared to Preoperatively	preoperatively and on the day of surgery	—
Change in Hematocrit on Day 0 Compared to Preoperatively	preoperatively and day of surgery	—
Change in Hemoglobin On Day 1 Compared to Preoperatively	preoperatively and one day after surgery	—
Change in Hematocrit on Day 1 Compared to Preoperatively	preoperatively and one day after surgery	—
Change in Hemoglobin on Day 2 Compared to Preoperatively	preoperatively and two days after surgery	—
Change in Hematocrit on Day 2 Compared to Preoperatively	preoperatively and two days after surgery	—
Drain Output	24 hours post-operatively	A measurement of the amount of blood drained from the knee.
Number of Autologous Transfusion Units Over the Course of the Hospital Stay	perioperatively	Units of autologous transfusion for each patient over the course of the hospital stay (an average of 3 days) were recorded.

Secondary

Measure	Time frame	Description
Change in International Normalized Ratio (INR) Level on Day 2 Compared to Preoperatively	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.
Range of Motion on Day 3	3 days postoperatively	A measurement of the degrees of motion of the operated knee three days after surgery.
Visual Analog Pain Scale on Day 3	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.
Range of Motion at 6 Weeks	6 weeks postoperatively	A measurement of the degrees of motion of the operated knee six weeks after surgery.
Visual Analog Pain Scale (at Rest) at 6 Weeks	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.
Visual Analog Pain Scale (During Activity) at 6 Weeks	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.
Visual Analog Pain Scale (During Therapy) at 6 Weeks	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.
Visual Analog Pain Scale (At Night) At 6 Weeks	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.

Countries

United States

Participant flow

Recruitment details

Patients undergoing total knee arthroplasty at the Hospital for Special Surgery from September 2010 to June 2012 were enrolled in a consecutive prospective manner on a voluntary basis.

Participants by arm

Arm	Count
Evicel Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.	98
no Evicel Patients will receive standard treatment for bleeding as practiced at HSS.	102
Total	200

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Physician Decision	0	2

Baseline characteristics

Characteristic	no Evicel	Evicel	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	61 Participants	64 Participants	125 Participants
Age, Categorical Between 18 and 65 years	41 Participants	34 Participants	75 Participants
Age Continuous	66.38 years STANDARD_DEVIATION 8.47	68.12 years STANDARD_DEVIATION 9.88	67 years STANDARD_DEVIATION 10
Region of Enrollment United States	102 participants	98 participants	200 participants
Sex: Female, Male Female	59 Participants	57 Participants	116 Participants
Sex: Female, Male Male	43 Participants	41 Participants	84 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	28 / 98	17 / 102
serious Total, serious adverse events	0 / 98	0 / 102