Trial · NCT03932240
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clot Degradation at 24 Hours Post-operatively | From induction of anesthesia to 24 hours postoperatively | This analysis includes the Intent to Treat Population, which is comprised on all participants regardless of if they completed the study per protocol. | microns per hour | MEDIAN |
| SECONDARY | Clot Strength | From induction of anesthesia to 24 hours postoperatively | Unfortunately, due to the required amount of blood necessary for triplicates of the primary outcome, there was not enough blood to examine clot strength. Due to the small amount of blood collected from neonates the samples were used for the outcome measures with the highest priority and the amount of remaining blood was not sufficient to assess clot strength. | ||
| SECONDARY | Clot Polymerization Kinetic | From induction of anesthesia to 24 hours postoperatively | Due to the maximum allowable blood to be taken from a neonate, there was not enough remaining blood available to examine clot polymerization kinetics. In order to carry out the degradation assay on neonatal fibrinogen, the study team improved the assay they originally intended to use and no longer did polymerization assays as part of the degradation assay. Due to the change in the degradation assay, the team was not able to collect additional blood for the clot polymerization kinetics assay. | ||
| SECONDARY | Fibrin Fiber Alignment | From induction of anesthesia to 24 hours postoperatively | This analysis includes the Intent to Treat Population. | black/white pixels | MEDIAN |
| SECONDARY | Interoperative Transfusion Requirement | During surgery (up to 6 hours) | This analysis includes the Intent to Treat Population. | ml/kg | MEDIAN |
| SECONDARY | Transfusion Requirements Within the First 24 Hours After Surgery | 24 hours postoperatively | The recording of transfusions in the intensive care unit (ICU) changed in the middle of this study and therefore transfusions were not consistently documented by the clinical staff, thus, the study investigators decided to not collect information about transfusions up to 24 hours after surgery from medical records as data could not be reliably analyzed. | ||
| SECONDARY | Amount of Post-operative Bleeding | Up to 24 hours postoperatively | This analysis includes the Intent to Treat Population. | ml/kg | MEDIAN |
| SECONDARY | Mechanical Ventilation Time | Time of extubation (up to 2 weeks) | This analysis includes the Intent to Treat Population. | hours | MEDIAN |
| SECONDARY | Length of ICU Stay | At discharge from ICU (typically up to 21 days) | This analysis includes the Intent to Treat Population. | days | MEDIAN |
| SECONDARY | Length of Hospital Stay | At discharge from hospital (up to 150 days) | This analysis includes the Intent to Treat Population. | days | MEDIAN |
| SECONDARY | Number of Adverse Events | Within seven days of surgery | This analysis includes the Intent to Treat Population. | adverse events | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Events of Postoperative Thrombosis | Within the first 24 hours of surgery | This analysis includes the Intent to Treat Population. | events | NUMBER |
| OTHER_PRE_SPECIFIED | Fibrinogen Plasma Level | From induction of anesthesia to 24 hours postoperatively | This analysis includes the Intent to Treat Population. | mcg/mL | MEDIAN |
| OTHER_PRE_SPECIFIED | Thrombin Plasma Level | From induction of anesthesia to 24 hours postoperatively | This analysis includes the Intent to Treat Population. | mcg/mL | MEDIAN |
| OTHER_PRE_SPECIFIED | FXIII Plasma Level | From induction of anesthesia to 24 hours postoperatively | This analysis includes the Intent to Treat Population. | mcg/mL | MEDIAN |
| OTHER_PRE_SPECIFIED | Von Willebrand Factor Plasma Level | From induction of anesthesia to 24 hours postoperatively | This analysis includes the Intent to Treat Population. | IU/mL | 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/NCT03932240/outcomes