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Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation (STAT)

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ClinicalTrials.gov Identifier: NCT00906204
Recruitment Status : Completed
First Posted : May 21, 2009
Results First Posted : December 7, 2015
Last Update Posted : December 7, 2015
Sponsor:
Collaborators:
Sanofi
University of Arizona
Wake Forest University
University of Nebraska
The Methodist Hospital System
Information provided by (Responsible Party):
R. Brian Stevens, MD, PhD, FACS, FAST, Wright State University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions End-Stage Renal Disease
Kidney Failure
Interventions Biological: Single-dose rabbit Anti-thymocyte Globulin induction
Biological: Divided-dose rabbit Anti-thymocyte Globulin induction
Enrollment 99
Recruitment Details Trial enrollment occurred between 3/30/2010 and 3/25/2014. Patients scheduled to undergo kidney transplantation were evaluated for trial suitability/enrollment in the transplant hospital or clinic just before transplantation, typically from a few hours to ~24 hours before transplantation.
Pre-assignment Details Occasionally patients were evaluated and thought to be suitable trial candidates until transplantation was imminent, when they were ruled out by last-minute observation of medical problems or donor shortcomings.
Arm/Group Title Single-dose Thymoglobulin Divided-dose Thymoglobulin
Hide Arm/Group Description

Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion

Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation

Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4

Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.

Period Title: Primary Endpoint (Early Safety)
Started 45 52
Completed 43 51
Not Completed 2 1
Reason Not Completed
Physician Decision             1             0
Untransplantable donor kidney             0             1
Withdrawal by Subject             1             0
Period Title: Secondary Endpoints (Long-term Safety)
Started 43 51
Completed 41 48
Not Completed 2 3
Reason Not Completed
Adverse Event             2             2
Death             0             1
Arm/Group Title Single-dose Thymoglobulin Divided-dose Thymoglobulin Total
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Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion

Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation

Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4

Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.

Total of all reporting groups
Overall Number of Baseline Participants 44 51 95
Hide Baseline Analysis Population Description
Patients who received a kidney transplant along with the study intervention, either single-dose or divided-dose rabbit anti-thymocyte globulin.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 51 participants 95 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
42
  95.5%
48
  94.1%
90
  94.7%
>=65 years
2
   4.5%
3
   5.9%
5
   5.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 51 participants 95 participants
48.0  (11.8) 49.0  (12.4) 48.5  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 51 participants 95 participants
Female
15
  34.1%
13
  25.5%
28
  29.5%
Male
29
  65.9%
38
  74.5%
67
  70.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants 51 participants 95 participants
44 51 95
Type of kidney donor  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 51 participants 95 participants
Living donor 26 29 55
Deceased donor 18 22 40
1.Primary Outcome
Title Composite Endpoint of 5 Components: Fever, Hypoxia, Hypotension, Cardiac Events, and Delayed Graft Function
Hide Description

The composite endpoint components and definitions are:

  • Fever: Body temperature ≥ 38.5˚C.
  • Hypotension: After rATG initiation, systolic blood pressure ≤ 90 mmHg requiring de novo treatment with vasopressors.
  • Hypoxia: During transplantation surgery, increase in FiO2 to ≥ 60% following rATG initiation. Following transplantation, starting in recovery room, FiO2 ≥ 50% or nasal cannula delivering ≥ 3 liters, either singly or combined, for > 12 hours out of a 24 hour period.
  • Cardiac events: Myocardial Infarction, clinically significant dysrhythmia (atrial fibrillation, atrial flutter, ventricular fibrillation and ventricular tachycardia)
  • Delayed graft function (DGF): Requirement for dialysis within 7 days of transplantation
Time Frame During first 7 days after kidney transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single-dose Thymoglobulin Divided-dose Thymoglobulin
Hide Arm/Group Description:

Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion

Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation

Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4

Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.

Overall Number of Participants Analyzed 44 51
Measure Type: Number
Unit of Measure: participants
13 12
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single-dose Thymoglobulin, Divided-dose Thymoglobulin
Comments The analysis compares the rates at which patients in each of the two groups cumulatively exceed the five composite endpoint thresholds. There are five safety outcomes monitored during the first seven post-transplantation days. The rates of observed vs. possible safety outcomes are compared.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A one-sided alpha = 0.05, 85% power, an event rate of 0.70, equivalence margin of 0.20. Sample size = 75 patients per dose group, a total of 150 patients. Data analyzed will be counts of patients in each group who experience one or more component events of the primary endpoint during postoperative days one through seven. The DSMB requested an interim analysis after 80 patients and recommended ending the trial because the primary endpoint had been robustly reached.
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Patient Survival
Hide Description Kaplan-Meier estimate of the number of patients who survived for the 12 months after kidney transplantation.
Time Frame 12 months post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single-dose Thymoglobulin Divided-dose Thymoglobulin
Hide Arm/Group Description:

Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion

Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation

Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4

Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.

Overall Number of Participants Analyzed 44 51
Measure Type: Number
Unit of Measure: participants
44 50
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single-dose Thymoglobulin, Divided-dose Thymoglobulin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Graft Survival
Hide Description Kaplan-Meier estimates of graft survival probability for 12 months after transplantation
Time Frame 12 months post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single-dose Thymoglobulin Divided-dose Thymoglobulin
Hide Arm/Group Description:

Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion

Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation

Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4

Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.

Overall Number of Participants Analyzed 44 51
Measure Type: Number
Unit of Measure: participants
42 50
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single-dose Thymoglobulin, Divided-dose Thymoglobulin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Acute Kidney Rejection
Hide Description Kaplan-Meier probability estimates of rejection rates
Time Frame 12 months post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single-dose Thymoglobulin Divided-dose Thymoglobulin
Hide Arm/Group Description:

Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion

Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation

Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4

Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.

Overall Number of Participants Analyzed 44 51
Measure Type: Number
Unit of Measure: participants
5 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single-dose Thymoglobulin, Divided-dose Thymoglobulin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
5.Secondary Outcome
Title Incomplete Thymoglobulin Infusion
Hide Description [Not Specified]
Time Frame First 7 days post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single-dose Thymoglobulin Divided-dose Thymoglobulin
Hide Arm/Group Description:

Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion

Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation

Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4

Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.

Overall Number of Participants Analyzed 44 51
Measure Type: Number
Unit of Measure: participants
3 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single-dose Thymoglobulin, Divided-dose Thymoglobulin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Kidney Function
Hide Description Estimated Glomerular Filtration Rate using the abbreviated MDRD formula (Modification of Diet in Renal Disease study)
Time Frame 12 months post-transplantation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single-dose Thymoglobulin Divided-dose Thymoglobulin
Hide Arm/Group Description:

Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion

Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation

Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4

Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.

Overall Number of Participants Analyzed 41 50
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m^2
59.3  (15.6) 61.3  (23.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single-dose Thymoglobulin, Divided-dose Thymoglobulin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame One year.
Adverse Event Reporting Description Patient laboratory values and events were systematically collected on post-transplantation days 0 through 7, then on days 21, 42, 90, 180, 270, and 365. Review and collection of enrolled patient data was by specific clinical research nurse specialists at each study site withoverall review by a clinical trial Contract Research Organization.
 
Arm/Group Title Single-dose Thymoglobulin Divided-dose Thymoglobulin
Hide Arm/Group Description

Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion

Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation

Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4

Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation.

All-Cause Mortality
Single-dose Thymoglobulin Divided-dose Thymoglobulin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Single-dose Thymoglobulin Divided-dose Thymoglobulin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/44 (52.27%)      21/51 (41.18%)    
Blood and lymphatic system disorders     
anemia   0/44 (0.00%)  0 1/51 (1.96%)  1
serum sickness   0/44 (0.00%)  0 1/51 (1.96%)  1
Cardiac disorders     
atrial fibrillation   1/44 (2.27%)  1 0/51 (0.00%)  0
Myocardial infarction   0/44 (0.00%)  0 1/51 (1.96%)  1
Congestive heart failure   0/44 (0.00%)  0 1/51 (1.96%)  1
Atypical chest pain   0/44 (0.00%)  0 1/51 (1.96%)  1
Endocrine disorders     
hyperkalemia   1/44 (2.27%)  1 2/51 (3.92%)  2
Gastrointestinal disorders     
abdominal fullness   0/44 (0.00%)  0 1/51 (1.96%)  1
abdominal pain   1/44 (2.27%)  1 0/51 (0.00%)  0
diarrhea   2/44 (4.55%)  2 2/51 (3.92%)  2
hemorrhage   0/44 (0.00%)  0 1/51 (1.96%)  1
nausea   2/44 (4.55%)  2 1/51 (1.96%)  1
General disorders     
death   0/44 (0.00%)  0 1/51 (1.96%)  1
orthostatic hypotension   1/44 (2.27%)  1 0/51 (0.00%)  0
Hepatobiliary disorders     
cholangitis   1/44 (2.27%)  1 0/51 (0.00%)  0
hepatitis C exposure   0/44 (0.00%)  0 1/51 (1.96%)  1
Immune system disorders     
Leukopenia   0/44 (0.00%)  0 1/51 (1.96%)  1
Infections and infestations     
BK virus   1/44 (2.27%)  1 0/51 (0.00%)  0
C. difficile   1/44 (2.27%)  1 1/51 (1.96%)  1
Pneumonia   4/44 (9.09%)  4 0/51 (0.00%)  0
Histoplasmosis   1/44 (2.27%)  1 0/51 (0.00%)  0
Sepsis   1/44 (2.27%)  1 1/51 (1.96%)  1
Urinary tract infection   1/44 (2.27%)  3 0/51 (0.00%)  0
Influenza   1/44 (2.27%)  1 0/51 (0.00%)  0
Viral Gasteroenteritis   0/44 (0.00%)  0 2/51 (3.92%)  2
Injury, poisoning and procedural complications     
rATG reaction   1/44 (2.27%)  1 0/51 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Chronic lymphoid leukemia   0/44 (0.00%)  0 1/51 (1.96%)  1
Basal cell carcinoma   1/44 (2.27%)  1 0/51 (0.00%)  0
Prostate cancer   0/44 (0.00%)  0 1/51 (1.96%)  1
Nervous system disorders     
Seizures   0/44 (0.00%)  0 1/51 (1.96%)  1
Renal and urinary disorders     
Acute tubular necrosis  [1]  2/44 (4.55%)  2 1/51 (1.96%)  1
Delayed graft function   1/44 (2.27%)  1 1/51 (1.96%)  1
Interstitial nephritis   0/44 (0.00%)  0 1/51 (1.96%)  1
Native nephrectomy   1/44 (2.27%)  2 0/51 (0.00%)  0
Nephrostomy tube placement   0/44 (0.00%)  0 1/51 (1.96%)  1
Perinephric hematoma   0/44 (0.00%)  0 1/51 (1.96%)  1
Rejection   3/44 (6.82%)  3 2/51 (3.92%)  2
Renal vein thrombosis   1/44 (2.27%)  1 0/51 (0.00%)  0
Urinary retention   0/44 (0.00%)  0 1/51 (1.96%)  1
Respiratory, thoracic and mediastinal disorders     
Pneumothorax   1/44 (2.27%)  1 0/51 (0.00%)  0
Surgical and medical procedures     
Wound hernia repair   1/44 (2.27%)  1 0/51 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
After post-transplantation day 7
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single-dose Thymoglobulin Divided-dose Thymoglobulin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/44 (100.00%)      49/51 (96.08%)    
Blood and lymphatic system disorders     
Anemia   14/44 (31.82%)  14/51 (27.45%) 
Hemorrhage   3/44 (6.82%)  7/51 (13.73%) 
Thrombocytopenia   14/44 (31.82%)  14/51 (27.45%) 
Cardiac disorders     
Hypertension   11/44 (25.00%)  15/51 (29.41%) 
Hypotension   4/44 (9.09%)  5/51 (9.80%) 
Tachycardia   5/44 (11.36%)  2/51 (3.92%) 
Endocrine disorders     
Hyperglycemia   18/44 (40.91%)  21/51 (41.18%) 
Hyperkalemia   8/44 (18.18%)  12/51 (23.53%) 
Hyperparathyroidism   0/44 (0.00%)  3/51 (5.88%) 
Hyperphosphatemia   5/44 (11.36%)  7/51 (13.73%) 
Hypokalemia   5/44 (11.36%)  7/51 (13.73%) 
Hypomagnesemia   15/44 (34.09%)  12/51 (23.53%) 
Hypophosphatemia   6/44 (13.64%)  6/51 (11.76%) 
Osteopenia   5/44 (11.36%)  4/51 (7.84%) 
Gastrointestinal disorders     
Abdominal pain   5/44 (11.36%)  3/51 (5.88%) 
Constipation   4/44 (9.09%)  7/51 (13.73%) 
Diarrhea   11/44 (25.00%)  10/51 (19.61%) 
Gastric reflux   3/44 (6.82%)  5/51 (9.80%) 
Nausea   4/44 (9.09%)  7/51 (13.73%) 
General disorders     
Edema   4/44 (9.09%)  9/51 (17.65%) 
Orthostatic hypotension   2/44 (4.55%)  4/51 (7.84%) 
Tacrolimus elevation/toxicity   5/44 (11.36%)  2/51 (3.92%) 
Hepatobiliary disorders     
Elevated liver enzymes   2/44 (4.55%)  4/51 (7.84%) 
Immune system disorders     
Leukocytosis   3/44 (6.82%)  10/51 (19.61%) 
Leukopenia   12/44 (27.27%)  18/51 (35.29%) 
Neutropenia   1/44 (2.27%)  3/51 (5.88%) 
Pancytopenia   2/44 (4.55%)  3/51 (5.88%) 
Infections and infestations     
BK virus   5/44 (11.36%)  6/51 (11.76%) 
C. difficile   3/44 (6.82%)  0/51 (0.00%) 
Respiratory infection  [1]  5/44 (11.36%)  6/51 (11.76%) 
Urinary tract infection   10/44 (22.73%)  11/51 (21.57%) 
Injury, poisoning and procedural complications     
Possible rATG reaction   2/44 (4.55%)  6/51 (11.76%) 
Metabolism and nutrition disorders     
Metabolic acidosis   7/44 (15.91%)  7/51 (13.73%) 
Hyperlipidemia   7/44 (15.91%)  2/51 (3.92%) 
Nervous system disorders     
Tremor   0/44 (0.00%)  5/51 (9.80%) 
Renal and urinary disorders     
Dysuria   3/44 (6.82%)  2/51 (3.92%) 
Elevated serum creatinine   8/44 (18.18%)  10/51 (19.61%) 
Proteinuria   5/44 (11.36%)  4/51 (7.84%) 
Rejection   2/44 (4.55%)  4/51 (7.84%) 
Respiratory, thoracic and mediastinal disorders     
Shortness of breath   2/44 (4.55%)  5/51 (9.80%) 
Skin and subcutaneous tissue disorders     
Pruritis   2/44 (4.55%)  4/51 (7.84%) 
Rash   2/44 (4.55%)  3/51 (5.88%) 
Surgical and medical procedures     
Hernia   3/44 (6.82%)  1/51 (1.96%) 
Wound complication  [2]  4/44 (9.09%)  3/51 (5.88%) 
Indicates events were collected by systematic assessment
[1]
Includes colds, sinusitis, bronchitis
[2]
Includes wound hematoma, seroma, drainage, slow healing
After an interim analysis at the trial mid-point, the trial was terminated because a futility trend analysis showed a >1.72% chance of the primary endpoint rates between the two groups achieving a significant difference with further enrollment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. R. Brian Stevens, MD, PhD, FACS
Organization: Wright State University Boonshoft School of Medicine, Dayton, Ohio, USA
Phone: 937-545-4817
Responsible Party: R. Brian Stevens, MD, PhD, FACS, FAST, Wright State University
ClinicalTrials.gov Identifier: NCT00906204     History of Changes
Other Study ID Numbers: 183-09-FB
First Submitted: May 19, 2009
First Posted: May 21, 2009
Results First Submitted: September 11, 2015
Results First Posted: December 7, 2015
Last Update Posted: December 7, 2015