Trial · NCT02227992
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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. |
| Secondary | Change From Baseline to Post-surgery in Haematocrit | From baseline up to hospital discharge (up to Day 44 post-surgery on Day 0) | Change from baseline to post-surgery in Haematocrit was reported. |
| 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) | Change from baseline to post-surgery in platelet count was reported. |
| Secondary | Estimated Volume of Blood Loss | Up to 1 day (intraoperative) | Estimated volume of intra-operative blood loss (including but not limited to the TBS) was reported. |
| Secondary | Number of Participants Who Received Blood Transfusions | Up to 44 days post-surgery on Day 0 | Number of participants who received blood transfusions (red blood cells \[RBCs\], whole blood, fresh frozen plasma, platelets, and cryoprecipitates) were reported. |
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.
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GET https://conductscience.org/api/trials/v1/NCT02227992/registered