Trial · NCT02227992
The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study
NCT02227992, Phase 3, Completed, Ethicon, Inc.; results first posted 2023-09-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study. Trials, record NCT02227992. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02227992
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study
- NCT number
- NCT02227992
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 40 participants, actual
- Lead sponsor
- Ethicon, Inc.
- Conditions
- Hemorrhage, Soft Tissue Bleeding, Hepatic Parenchyma Bleeding
- Interventions
- EVARREST™ Sealant Matrix, SURGICEL®
- First posted
- 2014-08-28
- Last updated
- 2023-09-08
- Other registries' IDs
- eudract:2013-003557-24
- Results first posted
- 2023-09-08
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Time to Haemostasis (TTH) | Up to 1 day (Intraoperative) | Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the target bleeding site (TBS) was observed. |
| Primary | Absolute Time to Haemostasis (TTH) by Age Group | Up to 1 day (Intraoperative) | Absolute TTH, defined as the absolute time elapsed from randomization to the last moment in time at which detectable bleeding at the TBS was observed. |
| Secondary | Percentage of Participants Achieving Haemostatic Success at 4 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure | 4 minutes post randomization (up to 1 day; intraoperative) | Percentage of participants achieving haemostatic success at 4 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported. |
| Secondary | Percentage of Participants Achieving Haemostatic Success at 10 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure | 10 minutes post randomization (up to 1 day; intraoperative) | Percentage of participants achieving haemostatic success at 10 minutes following randomization with no bleeding requiring treatment at the TBS occurring any time prior to final fascial closure were reported. |
| Secondary | Percentage of Participants With No Re-bleeding at the Target Bleeding Site | Up to 44 days post-surgery on Day 0 | Percentage of participants with no re-bleeding at the TBS were reported. |
| Secondary | Number of Participants With Adverse Events (AEs) That Were Potentially Related To Bleeding at the TBS | Up to 44 days post-surgery on Day 0 | Number of participants With AEs that were potentially related to bleeding at the TBS were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
| Secondary | Number of Participants With AEs That Were Potentially Related To Thrombotic Events | Up to 44 days post-surgery on Day 0 | Number of participants with AEs that were potentially related to thrombotic events (sponsor assessment) were reported. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
| Secondary | Number of Participants Who Required Re-treatment At The Target Bleeding Site | Up to 44 days post-surgery on Day 0 | Number of participants who required re-treatment at the TBS were reported. |
| Secondary | Number of Participants With Adverse Events | Up to 44 days post-surgery on Day 0 | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
| Secondary | Change From Baseline to Post-surgery in Haemoglobin | From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0) | Change from baseline to post-surgery in haemoglobin were reported. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Time to Haemostasis (TTH) | Up to 1 day (Intraoperative) | The Full Analysis Set (FAS; equivalent to the Intent-to-Treat \[ITT\] set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis. | Minutes | MEDIAN |
| SECONDARY | Percentage of Participants Achieving Haemostatic Success at 4 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure | 4 minutes post randomization (up to 1 day; intraoperative) | The FAS (equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Haemostatic Success at 10 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure | 10 minutes post randomization (up to 1 day; intraoperative) | The FAS (equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With No Re-bleeding at the Target Bleeding Site | Up to 44 days post-surgery on Day 0 | The FAS (equivalent to the ITT set) consisted of all randomized participants. Participants who did not complete the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs) That Were Potentially Related To Bleeding at the TBS | Up to 44 days post-surgery on Day 0 | The safety analysis set consists of all participants who received treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With AEs That Were Potentially Related To Thrombotic Events | Up to 44 days post-surgery on Day 0 | The safety analysis set consists of all participants who received treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Required Re-treatment At The Target Bleeding Site | Up to 44 days post-surgery on Day 0 | The safety analysis set consists of all participants who received treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events | Up to 44 days post-surgery on Day 0 | The safety analysis set consists of all participants who received treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Post-surgery in Haemoglobin | From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0) | The safety analysis set consists of all participants who received treatment. Here, 'N' (number of participants analyzed) signifies number of participants who were analyzed for this outcome measure. | grams/liter (g/L) | MEDIAN |
| SECONDARY | Change From Baseline to Post-surgery in Haematocrit | From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0) | The safety analysis set consists of all participants who received treatment. Here, 'N' (number of participants analyzed) signifies number of participants who were analyzed for this outcome measure. | Liter of cells per liter of blood (L/L) | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Time to Haemostasis (TTH) | EVARREST Sealant Matrix | 4.0 | Full Range 4.0 to 117.0 | Minutes | |
| Absolute Time to Haemostasis (TTH) | SURGICEL Absorbable Hemostat (Control) | 4.0 | Full Range 4.0 to 39.0 | Minutes | |
Percentage of Participants Achieving Haemostatic Success at 4 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure | EVARREST Sealant Matrix | 80.0 | 95% Confidence Interval 56.3 to 94.3 | Percentage of Participants | |
Percentage of Participants Achieving Haemostatic Success at 4 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure | SURGICEL Absorbable Hemostat (Control) | 60.0 | 95% Confidence Interval 36.1 to 80.9 | Percentage of Participants | |
Percentage of Participants Achieving Haemostatic Success at 10 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure | EVARREST Sealant Matrix | 95.0 | 95% Confidence Interval 75.1 to 99.9 | Percentage of Participants | |
Percentage of Participants Achieving Haemostatic Success at 10 Minutes Following Randomization With No Bleeding Requiring Treatment at the Target Bleeding Site Occurring Any Time Prior to Final Fascial Closure | SURGICEL Absorbable Hemostat (Control) | 90.0 | 95% Confidence Interval 68.3 to 98.8 | Percentage of Participants | |
| Percentage of Participants With No Re-bleeding at the Target Bleeding Site | EVARREST Sealant Matrix | 95.0 | Percentage of Participants | ||
| Percentage of Participants With No Re-bleeding at the Target Bleeding Site | SURGICEL Absorbable Hemostat (Control) | 85.0 | Percentage of Participants | ||
| Number of Participants With Adverse Events (AEs) That Were Potentially Related To Bleeding at the TBS | EVARREST Sealant Matrix | 1 | Participants | ||
| Number of Participants With Adverse Events (AEs) That Were Potentially Related To Bleeding at the TBS | SURGICEL Absorbable Hemostat (Control) | 3 | Participants |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EVARREST Sealant Matrix | 20 | |
| Overall Study | STARTED | SURGICEL Absorbable Hemostat (Control) | 20 | |
| Overall Study | COMPLETED | EVARREST Sealant Matrix | 19 | |
| Overall Study | COMPLETED | SURGICEL Absorbable Hemostat (Control) | 19 | |
| Overall Study | NOT COMPLETED | EVARREST Sealant Matrix | 1 | |
| Overall Study | NOT COMPLETED | SURGICEL Absorbable Hemostat (Control) | 1 |
Source ClinicalTrials.gov
Adverse events168
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | EVARREST Sealant Matrix | 2 | 20 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | SURGICEL Absorbable Hemostat (Control) | 1 | 20 | 1 |
| other | Coagulopathy | Blood and lymphatic system disorders | EVARREST Sealant Matrix | 1 | 20 | 1 |
| other | Coagulopathy | Blood and lymphatic system disorders | SURGICEL Absorbable Hemostat (Control) | 0 | 20 | 0 |
| other | Bradycardia | Cardiac disorders | EVARREST Sealant Matrix | 1 | 20 | 1 |
| other | Bradycardia | Cardiac disorders | SURGICEL Absorbable Hemostat (Control) | 3 | 20 | 3 |
| other | Tachycardia | Cardiac disorders | EVARREST Sealant Matrix | 10 | 20 | 10 |
| other | Tachycardia | Cardiac disorders | SURGICEL Absorbable Hemostat (Control) | 7 | 20 | 9 |
| other | Abdominal pain | Gastrointestinal disorders | EVARREST Sealant Matrix | 2 | 20 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | SURGICEL Absorbable Hemostat (Control) | 2 | 20 | 2 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EVARREST Sealant Matrix | 0 | 20 |
| Total, all-cause mortality | SURGICEL Absorbable Hemostat (Control) | 0 | 20 |
| Total, other adverse events | EVARREST Sealant Matrix | 18 | 20 |
| Total, other adverse events | SURGICEL Absorbable Hemostat (Control) | 17 | 20 |
| Total, serious adverse events | EVARREST Sealant Matrix | 4 | 20 |
| Total, serious adverse events | SURGICEL Absorbable Hemostat (Control) | 5 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| EVARREST Sealant Matrix vs SURGICEL Absorbable Hemostat (Control): Number of Participants With AEs That Were Potentially Related To Thrombotic Events | Trial comparisons |
| EVARREST Sealant Matrix vs SURGICEL Absorbable Hemostat (Control): Number of Participants With Adverse Events (AEs) That Were Potentially Related To Bleeding at the TBS | Trial comparisons |
| EVARREST Sealant Matrix vs SURGICEL Absorbable Hemostat (Control): Number of Participants Who Required Re-treatment At The Target Bleeding Site | Trial comparisons |
| EVARREST Sealant Matrix vs SURGICEL Absorbable Hemostat (Control): Number of Participants With Adverse Events | Trial comparisons |
| EVARREST Sealant Matrix vs SURGICEL Absorbable Hemostat (Control): deaths from any cause | Trial comparisons |
| EVARREST Sealant Matrix vs SURGICEL Absorbable Hemostat (Control): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02227992
GET https://conductscience.org/api/trials/v1/NCT02227992/results?page=2