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Trial record 1 of 1 for:    NCT02780869
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HEMOBLAST Pivotal Clinical Investigation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02780869
Recruitment Status : Completed
First Posted : May 24, 2016
Results First Posted : November 7, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Biom'Up France SAS

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Hemostasis
Interventions Device: HEMOBLAST Bellows
Device: Absorbable gelatin sponge, USP with thrombin
Enrollment 258
Recruitment Details First subject completed follow-up: August 19, 2016 Last patient completed follow-up: January 18, 2017
Pre-assignment Details Subject enrollment occurred after the subject met preoperative eligibility criteria, gave written informed consent, and met intraoperative eligibility criteria. Subjects were randomized and treated subsequent to enrollment. Subjects could withdraw or be withdrawn from the study at any time after enrollment, including prior to treatment.
Arm/Group Title Investigational Control
Hide Arm/Group Description

HEMOBLAST Bellows

HEMOBLAST Bellows

Absorbable gelatin sponge, USP with thrombin

Absorbable gelatin sponge, USP with thrombin

Period Title: Overall Study
Started 175 83
Completed 162 74
Not Completed 13 9
Arm/Group Title Investigational Control Total
Hide Arm/Group Description HEMOBLAST Bellows Absorbable gelatin sponge, USP with thrombin Total of all reporting groups
Overall Number of Baseline Participants 175 83 258
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 175 participants 83 participants 258 participants
56.9  (14.79) 56.2  (14.62) 56.7  (14.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 83 participants 258 participants
Female
106
  60.6%
49
  59.0%
155
  60.1%
Male
69
  39.4%
34
  41.0%
103
  39.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 83 participants 258 participants
Hispanic or Latino
17
   9.7%
7
   8.4%
24
   9.3%
Not Hispanic or Latino
157
  89.7%
76
  91.6%
233
  90.3%
Unknown or Not Reported
1
   0.6%
0
   0.0%
1
   0.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 175 participants 83 participants 258 participants
American Indian or Alaska Native
3
   1.7%
0
   0.0%
3
   1.2%
Asian
7
   4.0%
5
   6.0%
12
   4.7%
Native Hawaiian or Other Pacific Islander
6
   3.4%
3
   3.6%
9
   3.5%
Black or African American
25
  14.3%
14
  16.9%
39
  15.1%
White
123
  70.3%
57
  68.7%
180
  69.8%
More than one race
11
   6.3%
4
   4.8%
15
   5.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Proportion of Subjects Achieving Hemostasis
Hide Description The proportion of subjects achieving hemostasis at 6 minutes post-hemostat application was calculated. Hemostasis was defined as a grade of 0 (None/Dry) on the Surface Bleeding Severity Scale, with additional grades, ranging from 1 (Minimal/Oozing) to 5 (Extreme/Gushing), considered a failure of hemostasis.
Time Frame Intraoperative, 6 Minutes Post-Application
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population was defined as the Time-To-Hemostasis (TTH) population and included all subjects who were randomized, received study intervention, and had a TTH assessment recorded.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
HEMOBLAST Bellows
Absorbable gelatin sponge, USP with thrombin
Overall Number of Participants Analyzed 159 83
Measure Type: Count of Participants
Unit of Measure: Participants
148
  93.1%
61
  73.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational, Control
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The primary endpoint was designed to establish comparable efficacy based upon a non-inferiority margin of 10% for the difference in the probability of TTH within 6 minutes comparing HEMOBLAST™ to G+T (HEMOBLAST™– G+T). Letting θ denote the true difference in the probability of hemostasis at 6 minutes between HEMOBLAST™ to G+T, the trial will test the null hypothesis H0: θ ≤ -0.10 vs. the alternative hypothesis HA : θ > -0.10 using a one-sided level 0.025 test.
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified adjustments for surgery type were made using the Cochran-Mantel-Haenszel weighting.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Investigational, Control
Comments A secondary endpoint of superiority of HEMOBLAST relative to G+T for success at achieving hemostasis within 6 minutes was evaluated.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments Adjustment for mulitple comparisons were made when assessing secondary endpoints using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Product Preparation Time
Hide Description The average time from the opening of the package to the product being ready to use, measured in minutes and seconds.
Time Frame Intraoperative
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population was defined as the Time-To-Hemostasis (TTH) population and included all subjects who were randomized, received study intervention, and had a TTH assessment recorded.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
HEMOBLAST Bellows
Absorbable gelatin sponge, USP with thrombin
Overall Number of Participants Analyzed 159 83
Mean (Standard Deviation)
Unit of Measure: Minutes
0.37  (0.16) 2.40  (0.794)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational, Control
Comments The difference in mean preparation time was tested using a linear regression model with stratified adjustment for surgery type.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjustment for mulitple comparisons were made when assessing secondary endpoints using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05
Method Regression, Linear
Comments [Not Specified]
3.Secondary Outcome
Title Proportion of Subjects Achieving Hemostasis
Hide Description The proportion of subjects achieving hemostasis at 3 minutes post-hemostat application was calculated
Time Frame Intraoperative, 3 Minutes Post-Application
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analysis population was defined as the Time-To-Hemostasis (TTH) population and included all subjects who were randomized, received study intervention, and had a TTH assessment recorded.
Arm/Group Title Investigational Control
Hide Arm/Group Description:
HEMOBLAST Bellows
Absorbable gelatin sponge, USP with thrombin
Overall Number of Participants Analyzed 159 83
Measure Type: Count of Participants
Unit of Measure: Participants
113
  71.1%
38
  45.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Investigational, Control
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The difference in the probability of hemostasis within 3 minutes was tested using a logistic regression model with stratified adjustment for surgery type.
Statistical Test of Hypothesis P-Value <0.0001
Comments Adjustment for multiple comparisons when assessing secondary endpoints was performed using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05.
Method Regression, Logistic
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Investigational, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments The difference in the probability of hemostasis within 3 minutes was tested using a logistic regression model with stratified adjustment for surgery type.
Statistical Test of Hypothesis P-Value 0.0001
Comments Adjustment for multiple comparisons when assessing secondary endpoints was performed using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05.
Method Regression, Logistic
Comments [Not Specified]
Time Frame Enrollment until completion of 6-week follow-up visit
Adverse Event Reporting Description All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as ‘any untoward medical occurrence in a subject.’ An AE related to a device (adverse device effect, ADE) is defined as ‘any untoward and unintended response to an investigational medical device.’
 
Arm/Group Title Investigational Control
Hide Arm/Group Description HEMOBLAST Bellows Absorbable gelatin sponge, USP with thrombin
All-Cause Mortality
Investigational Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/175 (0.00%)   3/83 (3.61%) 
Hide Serious Adverse Events
Investigational Control
Affected / at Risk (%) Affected / at Risk (%)
Total   19/175 (10.86%)   11/83 (13.25%) 
Blood and lymphatic system disorders     
Anemia   1/175 (0.57%)  1/83 (1.20%) 
Thrombocytopenia   0/175 (0.00%)  1/83 (1.20%) 
Cardiac disorders     
Arrhythmia   3/175 (1.71%)  2/83 (2.41%) 
Aortic dissection   1/175 (0.57%)  0/83 (0.00%) 
General disorders     
Death   0/175 (0.00%)  3/83 (3.61%) 
Fever   0/175 (0.00%)  1/83 (1.20%) 
Ascites   1/175 (0.57%)  0/83 (0.00%) 
Pleural effusion   2/175 (1.14%)  1/83 (1.20%) 
Hemothorax   1/175 (0.57%)  0/83 (0.00%) 
Hypotension   0/175 (0.00%)  2/83 (2.41%) 
Melena   0/175 (0.00%)  1/83 (1.20%) 
Nausea   1/175 (0.57%)  0/83 (0.00%) 
Pain   1/175 (0.57%)  0/83 (0.00%) 
Respiratory insufficiency   2/175 (1.14%)  1/83 (1.20%) 
Syncope   1/175 (0.57%)  1/83 (1.20%) 
Pulmonary embolism   1/175 (0.57%)  0/83 (0.00%) 
Stroke   1/175 (0.57%)  1/83 (1.20%) 
Vomiting   1/175 (0.57%)  0/83 (0.00%) 
Immune system disorders     
Skin rash/hives   1/175 (0.57%)  0/83 (0.00%) 
Infections and infestations     
Bacteremia   1/175 (0.57%)  0/83 (0.00%) 
Infection   3/175 (1.71%)  0/83 (0.00%) 
Injury, poisoning and procedural complications     
Fracture   0/175 (0.00%)  1/83 (1.20%) 
Nervous system disorders     
Delirium   0/175 (0.00%)  1/83 (1.20%) 
Product Issues     
RA lead dislodgement  [1]  0/175 (0.00%)  1/83 (1.20%) 
Renal and urinary disorders     
Acute kidney injury   0/175 (0.00%)  1/83 (1.20%) 
Skin and subcutaneous tissue disorders     
Dehisence   1/175 (0.57%)  1/83 (1.20%) 
Seroma   1/175 (0.57%)  0/83 (0.00%) 
Surgical and medical procedures     
Right bronchopleural fistula   1/175 (0.57%)  0/83 (0.00%) 
Indicates events were collected by systematic assessment
[1]
RA lead dislodgement
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Investigational Control
Affected / at Risk (%) Affected / at Risk (%)
Total   84/175 (48.00%)   47/83 (56.63%) 
Blood and lymphatic system disorders     
Abnormal bloodwork   13/175 (7.43%)  5/83 (6.02%) 
Anemia   10/175 (5.71%)  9/83 (10.84%) 
Cardiac disorders     
Arrythmia   16/175 (9.14%)  7/83 (8.43%) 
Gastrointestinal disorders     
Constipation/ileus   12/175 (6.86%)  5/83 (6.02%) 
General disorders     
Fluid overload   8/175 (4.57%)  5/83 (6.02%) 
Nausea   15/175 (8.57%)  3/83 (3.61%) 
Pain   25/175 (14.29%)  11/83 (13.25%) 
Infections and infestations     
Infection  [1]  7/175 (4.00%)  6/83 (7.23%) 
Skin and subcutaneous tissue disorders     
Wound related   12/175 (6.86%)  4/83 (4.82%) 
Indicates events were collected by systematic assessment
[1]
Non wound-related
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Rachel Hoffman, Vice President Clinical Operations North America
Organization: Biom'up
Phone: 404-702-9253
EMail: r.hoffman@biomup.com
Layout table for additonal information
Responsible Party: Biom'Up France SAS
ClinicalTrials.gov Identifier: NCT02780869    
Other Study ID Numbers: ETC 2015-002
First Submitted: May 19, 2016
First Posted: May 24, 2016
Results First Submitted: October 8, 2018
Results First Posted: November 7, 2018
Last Update Posted: December 27, 2018