The Fibrin Pad Cardiovascular Study
Sponsor
Ethicon, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01681030
Collaborator
(none)
42
6
3
13.1
7
0.5
Study Details
Study Description
Brief Summary
This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Controlled, Comparative Phase II Study Evaluating the Safety and Effectiveness of EVARREST™ Fibrin Sealant Patch as an Adjunct to Hemostasis During Cardiovascular Surgery
Actual Study Start Date
:
Aug 1, 2012
Actual Primary Completion Date
:
Aug 1, 2013
Actual Study Completion Date
:
Sep 3, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EVARREST™ EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin). |
Biological: EVARREST™
EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
|
| Active Comparator: Topical hemostat Equine collagen with Human Fibrinogen and Human Thrombin |
Biological: Topical hemostat
Equine collagen with Human Fibrinogen and Human Thrombin
|
| Active Comparator: Standard of Care SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. |
Other: Standard of Care
SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
|
Outcome Measures
Primary Outcome Measures
- Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application. [Intraoperative, 3 minutes following treatment application]
Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closur
Secondary Outcome Measures
- Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application [Intraoperative, 6 minutes following treatment application]
The number of subjects achieving hemostatic success at 6 minutes following treatment application.
- Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application [Intraoperative, 10 minutes following treatment application]
Number of subjects achieving hemostatic success at 10 minutes following treatment application.
- Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment [Intra-operative, prior initiation of final chest wall closure. Safety Issue:]
The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had re-bleeding requiring treatment
- Number of Participants With Adverse Events Potentially Related to Thrombotic Events [30 days (+ 14 days) following surgery]
The number of subjects with an adverse event potentially related to a thrombotic event
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass;
-
Subjects must be willing to participate in the study and provide written informed consent.
Exclusion Criteria:
-
Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
-
Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 30 day follow up period after surgery.
-
Female subjects who are pregnant or nursing.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Investigation Site #5 | Indianapolis | Indiana | United States | 46260 |
| 2 | Clinical Investigation Site #6 | Kansas City | Missouri | United States | 64111 |
| 3 | Clinical Investigation Site #4 | Camden | New Jersey | United States | 08103 |
| 4 | Clinical Investigation Site #1 | Paterson | New Jersey | United States | 07503 |
| 5 | Clinical Investigation Site #3 | New York | New York | United States | 10016 |
| 6 | Clinical Investigation Site #2 | New York | New York | United States | 10075 |
Sponsors and Collaborators
- Ethicon, Inc.
Investigators
- Study Director: Jerome Riebman, MD, Ethicon, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT01681030
Other Study ID Numbers:
- 400-12-002
First Posted:
Sep 7, 2012
Last Update Posted:
Jun 12, 2018
Last Verified:
May 1, 2018
Study Results
Participant Flow
| Recruitment Details | Subjects were recruited from September 17, 2012 through September 3, 2013 at hospitals and medical centers throughout the United States. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | EVARREST Fibrin Sealant Patch | Topical Hemostat | Standard of Care (SoC) |
|---|---|---|---|
| Arm/Group Description | EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin. | Equine collagen sponge with Human Fibrinogen and Human Thrombin | SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. |
| Period Title: Overall Study | |||
| STARTED | 13 | 18 | 11 |
| COMPLETED | 13 | 18 | 11 |
| NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | EVARREST Fibrin Sealant Patch | Topical Hemostat | Standard of Care (SoC) | Total |
|---|---|---|---|---|
| Arm/Group Description | EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin. | Equine collagen sponge with Human Fibrinogen and Human Thrombin | SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. | Total of all reporting groups |
| Overall Participants | 13 | 18 | 11 | 42 |
| Age (Years) [Mean (Standard Deviation) ] | ||||
| Age |
56.0
(15.1)
|
59.8
(12.9)
|
60.5
(15.4)
|
58.8
(14.0)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
4
30.8%
|
3
16.7%
|
2
18.2%
|
9
21.4%
|
| Male |
9
69.2%
|
15
83.3%
|
9
81.8%
|
33
78.6%
|
| Race/Ethnicity, Customized (Number) [Number] | ||||
| Asian |
0
0%
|
0
0%
|
1
9.1%
|
1
2.4%
|
| Black or African American |
2
15.4%
|
0
0%
|
2
18.2%
|
4
9.5%
|
| White/Caucasian |
9
69.2%
|
11
61.1%
|
6
54.5%
|
26
61.9%
|
| Hispanic or Latino |
2
15.4%
|
7
38.9%
|
2
18.2%
|
11
26.2%
|
| BMI Category (Participant) [Number] | ||||
| Normal |
5
|
7
|
4
|
16
|
| Overweight |
3
|
5
|
2
|
10
|
| Obese |
3
|
5
|
4
|
12
|
| Morbidly obese |
2
|
1
|
1
|
4
|
Outcome Measures
| Title | Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application. |
|---|---|
| Description | Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closur |
| Time Frame | Intraoperative, 3 minutes following treatment application |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | EVARREST Fibrin Sealant Patch | Topical Hemostat | Standard of Care (SoC) |
|---|---|---|---|
| Arm/Group Description | EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin. | Equine collagen sponge with Human Fibrinogen and Human Thrombin | SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. |
| Measure Participants | 13 | 18 | 11 |
| Count of Participants [Participants] |
12
92.3%
|
6
33.3%
|
5
45.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | EVARREST Fibrin Sealant Patch |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Proportion |
| Estimated Value | 0.923 | |
| Confidence Interval |
(2-Sided) 95% 0.640 to 0.998 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CI for EVARREST Group | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Topical Hemostat |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Proportion |
| Estimated Value | 0.333 | |
| Confidence Interval |
(2-Sided) 95% 0.133 to 0.590 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CI for Topical Hemostat group | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Standard of Care (SoC) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Proportion |
| Estimated Value | 0.455 | |
| Confidence Interval |
(2-Sided) 95% 0.167 to 0.766 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | CI for Standard of Care group | |
| Title | Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application |
|---|---|
| Description | The number of subjects achieving hemostatic success at 6 minutes following treatment application. |
| Time Frame | Intraoperative, 6 minutes following treatment application |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | EVARREST Fibrin Sealant Patch | Topical Hemostat | Standard of Care (SoC) |
|---|---|---|---|
| Arm/Group Description | EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin. | Equine collagen sponge with Human Fibrinogen and Human Thrombin | SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. |
| Measure Participants | 13 | 18 | 11 |
| Count of Participants [Participants] |
12
92.3%
|
11
61.1%
|
7
63.6%
|
| Title | Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application |
|---|---|
| Description | Number of subjects achieving hemostatic success at 10 minutes following treatment application. |
| Time Frame | Intraoperative, 10 minutes following treatment application |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | EVARREST Fibrin Sealant Patch | Topical Hemostat | Standard of Care (SoC) |
|---|---|---|---|
| Arm/Group Description | EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin. | Equine collagen sponge with Human Fibrinogen and Human Thrombin | SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. |
| Measure Participants | 13 | 18 | 11 |
| Count of Participants [Participants] |
12
92.3%
|
12
66.7%
|
8
72.7%
|
| Title | Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment |
|---|---|
| Description | The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had re-bleeding requiring treatment |
| Time Frame | Intra-operative, prior initiation of final chest wall closure. Safety Issue: |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subjects who established TBS hemostasis at 3 minutes |
| Arm/Group Title | EVARREST Fibrin Sealant Patch | Topical Hemostat | Standard of Care (SoC) |
|---|---|---|---|
| Arm/Group Description | EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin. | Equine collagen sponge with Human Fibrinogen and Human Thrombin | SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. |
| Measure Participants | 12 | 11 | 5 |
| Count of Participants [Participants] |
0
0%
|
5
27.8%
|
0
0%
|
| Title | Number of Participants With Adverse Events Potentially Related to Thrombotic Events |
|---|---|
| Description | The number of subjects with an adverse event potentially related to a thrombotic event |
| Time Frame | 30 days (+ 14 days) following surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | EVARREST Fibrin Sealant Patch | Topical Hemostat | Standard of Care (SoC) |
|---|---|---|---|
| Arm/Group Description | EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin. | Equine collagen sponge with Human Fibrinogen and Human Thrombin | SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. |
| Measure Participants | 13 | 18 | 11 |
| Count of Participants [Participants] |
0
0%
|
2
11.1%
|
2
18.2%
|
Adverse Events
| Time Frame | From surgical procedure through the 30 day follow-up (+/- 14 days) | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | EVARREST Fibrin Sealant Patch | Topical Hemostat | Standard of Care (SoC) | |||
| Arm/Group Description | EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin. | Equine collagen sponge with Human Fibrinogen and Human Thrombin | SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. | |||
All Cause Mortality |
||||||
| EVARREST Fibrin Sealant Patch | Topical Hemostat | Standard of Care (SoC) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| EVARREST Fibrin Sealant Patch | Topical Hemostat | Standard of Care (SoC) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/13 (23.1%) | 10/18 (55.6%) | 6/11 (54.5%) | |||
| Blood and lymphatic system disorders | ||||||
| COAGULOPATHY | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| ANAEMIA | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| Cardiac disorders | ||||||
| VENTRICULAR FIBRILLATION | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| SINUS BRADYCARDIA | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| MYOCARDIAL ISCHAEMIA | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| CARDIAC TAMPONADE | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| CARDIAC FAILURE CONGESTIVE | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| CARDIAC ARREST | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| ATRIOVENTRICULAR BLOCK COMPLETE | 0/13 (0%) | 3/18 (16.7%) | 1/11 (9.1%) | |||
| ATRIAL FLUTTER | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| ATRIAL FIBRILLATION | 2/13 (15.4%) | 2/18 (11.1%) | 1/11 (9.1%) | |||
| Infections and infestations | ||||||
| PNEUMONIA | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| CLOSTRIDIAL INFECTION | 1/13 (7.7%) | 0/18 (0%) | 0/11 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| POST PROCEDURAL HAEMORRHAGE | 0/13 (0%) | 2/18 (11.1%) | 0/11 (0%) | |||
| Nervous system disorders | ||||||
| SPINAL CORD ISCHAEMIA | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| CEREBROVASCULAR ACCIDENT | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| Psychiatric disorders | ||||||
| ALCOHOL WITHDRAWAL SYNDROME | 2/13 (15.4%) | 0/18 (0%) | 0/11 (0%) | |||
| Renal and urinary disorders | ||||||
| RENAL FAILURE | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| RESPIRATORY FAILURE | 0/13 (0%) | 1/18 (5.6%) | 2/11 (18.2%) | |||
| PLEURAL EFFUSION | 1/13 (7.7%) | 1/18 (5.6%) | 1/11 (9.1%) | |||
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 0/13 (0%) | 0/18 (0%) | 2/11 (18.2%) | |||
| Vascular disorders | ||||||
| DEEP VEIN THROMBOSIS | 0/13 (0%) | 1/18 (5.6%) | 1/11 (9.1%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| EVARREST Fibrin Sealant Patch | Topical Hemostat | Standard of Care (SoC) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/13 (100%) | 18/18 (100%) | 11/11 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| THROMBOCYTOPENIA | 1/13 (7.7%) | 4/18 (22.2%) | 2/11 (18.2%) | |||
| LEUKOCYTOSIS | 0/13 (0%) | 2/18 (11.1%) | 0/11 (0%) | |||
| COAGULOPATHY | 1/13 (7.7%) | 1/18 (5.6%) | 2/11 (18.2%) | |||
| ANAEMIA | 3/13 (23.1%) | 5/18 (27.8%) | 3/11 (27.3%) | |||
| Cardiac disorders | ||||||
| VENTRICULAR FIBRILLATION | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| TACHYCARDIA | 0/13 (0%) | 2/18 (11.1%) | 0/11 (0%) | |||
| SUPRAVENTRICULAR TACHYCARDIA | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| SINUS BRADYCARDIA | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| MYOCARDIAL ISCHAEMIA | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| CARDIAC TAMPONADE | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| CARDIAC FAILURE CONGESTIVE | 0/13 (0%) | 1/18 (5.6%) | 1/11 (9.1%) | |||
| CARDIAC FAILURE | 1/13 (7.7%) | 0/18 (0%) | 0/11 (0%) | |||
| CARDIAC ARREST | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| ATRIOVENTRICULAR BLOCK COMPLETE | 0/13 (0%) | 3/18 (16.7%) | 1/11 (9.1%) | |||
| ATRIOVENTRICULAR BLOCK | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| ATRIAL FLUTTER | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| ATRIAL FIBRILLATION | 3/13 (23.1%) | 5/18 (27.8%) | 3/11 (27.3%) | |||
| Gastrointestinal disorders | ||||||
| VOMITING | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| PEPTIC ULCER | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| NAUSEA | 2/13 (15.4%) | 4/18 (22.2%) | 1/11 (9.1%) | |||
| GASTRITIS | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| FLATULENCE | 1/13 (7.7%) | 0/18 (0%) | 0/11 (0%) | |||
| CONSTIPATION | 2/13 (15.4%) | 3/18 (16.7%) | 3/11 (27.3%) | |||
| General disorders | ||||||
| PYREXIA | 2/13 (15.4%) | 0/18 (0%) | 2/11 (18.2%) | |||
| OEDEMA PERIPHERAL | 0/13 (0%) | 3/18 (16.7%) | 2/11 (18.2%) | |||
| OEDEMA | 0/13 (0%) | 3/18 (16.7%) | 2/11 (18.2%) | |||
| HYPOTHERMIA | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| FATIGUE | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| EFFUSION | 0/13 (0%) | 1/18 (5.6%) | 1/11 (9.1%) | |||
| CHEST PAIN | 1/13 (7.7%) | 0/18 (0%) | 0/11 (0%) | |||
| Infections and infestations | ||||||
| URINARY TRACT INFECTION | 0/13 (0%) | 1/18 (5.6%) | 1/11 (9.1%) | |||
| STAPHYLOCOCCAL INFECTION | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| PNEUMONIA | 0/13 (0%) | 1/18 (5.6%) | 1/11 (9.1%) | |||
| FUNGAL INFECTION | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| CLOSTRIDIAL INFECTION | 1/13 (7.7%) | 0/18 (0%) | 0/11 (0%) | |||
| BRONCHITIS | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| BACTERAEMIA | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| Injury, poisoning and procedural complications | ||||||
| TRANSFUSION-RELATED ACUTE LUNG INJURY | 1/13 (7.7%) | 0/18 (0%) | 0/11 (0%) | |||
| PROCEDURAL PAIN | 1/13 (7.7%) | 1/18 (5.6%) | 1/11 (9.1%) | |||
| POST PROCEDURAL HAEMORRHAGE | 0/13 (0%) | 2/18 (11.1%) | 0/11 (0%) | |||
| LACERATION | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| INCISION SITE PAIN | 1/13 (7.7%) | 0/18 (0%) | 0/11 (0%) | |||
| ANAEMIA POSTOPERATIVE | 1/13 (7.7%) | 0/18 (0%) | 0/11 (0%) | |||
| Investigations | ||||||
| RED BLOOD CELL COUNT DECREASED | 1/13 (7.7%) | 0/18 (0%) | 0/11 (0%) | |||
| PLATELET COUNT DECREASED | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| HAEMOGLOBIN DECREASED | 1/13 (7.7%) | 0/18 (0%) | 0/11 (0%) | |||
| HAEMATOCRIT DECREASED | 1/13 (7.7%) | 0/18 (0%) | 0/11 (0%) | |||
| BLOOD FIBRINOGEN INCREASED | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| Metabolism and nutrition disorders | ||||||
| METABOLIC ACIDOSIS | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| LACTIC ACIDOSIS | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| HYPOVOLAEMIA | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| HYPOPHOSPHATAEMIA | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| HYPONATRAEMIA | 2/13 (15.4%) | 1/18 (5.6%) | 0/11 (0%) | |||
| HYPOMAGNESAEMIA | 1/13 (7.7%) | 0/18 (0%) | 0/11 (0%) | |||
| HYPOKALAEMIA | 1/13 (7.7%) | 0/18 (0%) | 0/11 (0%) | |||
| HYPOGLYCAEMIA | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| HYPOCALCAEMIA | 1/13 (7.7%) | 1/18 (5.6%) | 2/11 (18.2%) | |||
| HYPERVOLAEMIA | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| HYPERNATRAEMIA | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| HYPERKALAEMIA | 1/13 (7.7%) | 2/18 (11.1%) | 0/11 (0%) | |||
| HYPERGLYCAEMIA | 1/13 (7.7%) | 2/18 (11.1%) | 0/11 (0%) | |||
| DIABETES MELLITUS INADEQUATE CONTROL | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| ACIDOSIS | 0/13 (0%) | 1/18 (5.6%) | 1/11 (9.1%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| MUSCULOSKELETAL PAIN | 1/13 (7.7%) | 1/18 (5.6%) | 0/11 (0%) | |||
| FRACTURE MALUNION | 1/13 (7.7%) | 0/18 (0%) | 0/11 (0%) | |||
| Nervous system disorders | ||||||
| SPINAL CORD ISCHAEMIA | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| CEREBROVASCULAR ACCIDENT | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| Psychiatric disorders | ||||||
| DELIRIUM | 0/13 (0%) | 1/18 (5.6%) | 1/11 (9.1%) | |||
| CONFUSIONAL STATE | 2/13 (15.4%) | 0/18 (0%) | 0/11 (0%) | |||
| ANXIETY | 0/13 (0%) | 0/18 (0%) | 2/11 (18.2%) | |||
| ALCOHOL WITHDRAWAL SYNDROME | 2/13 (15.4%) | 0/18 (0%) | 0/11 (0%) | |||
| AGITATION | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| Renal and urinary disorders | ||||||
| URINARY RETENTION | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| RENAL FAILURE | 1/13 (7.7%) | 1/18 (5.6%) | 0/11 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| RESPIRATORY FAILURE | 0/13 (0%) | 2/18 (11.1%) | 2/11 (18.2%) | |||
| PULMONARY OEDEMA | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| PULMONARY CONGESTION | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| PRODUCTIVE COUGH | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| PNEUMOTHORAX | 1/13 (7.7%) | 4/18 (22.2%) | 0/11 (0%) | |||
| PLEURAL EFFUSION | 7/13 (53.8%) | 6/18 (33.3%) | 5/11 (45.5%) | |||
| OROPHARYNGEAL PAIN | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| DYSPNOEA | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| COUGH | 1/13 (7.7%) | 0/18 (0%) | 0/11 (0%) | |||
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 0/13 (0%) | 0/18 (0%) | 2/11 (18.2%) | |||
| CHRONIC OBSTRUCTIVE PULMONARY | 0/13 (0%) | 0/18 (0%) | 2/11 (18.2%) | |||
| ATELECTASIS | 4/13 (30.8%) | 7/18 (38.9%) | 4/11 (36.4%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| SKIN ULCER | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| ERYTHEMA | 0/13 (0%) | 2/18 (11.1%) | 0/11 (0%) | |||
| DERMATITIS CONTACT | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| DECUBITUS ULCER | 0/13 (0%) | 0/18 (0%) | 1/11 (9.1%) | |||
| Surgical and medical procedures | ||||||
| THORACIC CAVITY DRAINAGE | 1/13 (7.7%) | 0/18 (0%) | 0/11 (0%) | |||
| Vascular disorders | ||||||
| HYPOTENSION | 3/13 (23.1%) | 7/18 (38.9%) | 2/11 (18.2%) | |||
| HYPERTENSION | 0/13 (0%) | 1/18 (5.6%) | 0/11 (0%) | |||
| HAEMATOMA | 0/13 (0%) | 1/18 (5.6%) | 1/11 (9.1%) | |||
| DEEP VEIN THROMBOSIS | 0/13 (0%) | 2/18 (11.1%) | 2/11 (18.2%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Richard Kocharian, MD, PhD |
|---|---|
| Organization | Ethicon, Inc |
| Phone | +1-908-218-2013 |
| rkochar1@its.jnj.com |
Responsible Party:
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT01681030
Other Study ID Numbers:
- 400-12-002
First Posted:
Sep 7, 2012
Last Update Posted:
Jun 12, 2018
Last Verified:
May 1, 2018