Trial · NCT02227992
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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 |
| SECONDARY | Change From Baseline to Post-surgery in Platelet Count | 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. | 10^9 cells per liter | MEDIAN |
| SECONDARY | Estimated Volume of Blood Loss | Up to 1 day (intraoperative) | The FAS consisted of all randomized participants. Participants who did not completed the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis. | Milliliter (mL) | MEDIAN |
| SECONDARY | Number of Participants Who Received Blood Transfusions | Up to 44 days post-surgery on Day 0 | The FAS consisted of all randomized participants. Participants who did not completed the procedure with the use of EVARREST or SURGICEL after randomization were included in the FAS analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Absolute Time to Haemostasis (TTH) by Age Group | Up to 1 day (Intraoperative) | The Full Analysis Set (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. Here 'n' (number analyzed) signifies number of participants analyzed for specified categories. | Minutes | MEDIAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02227992/outcomes