Trial · NCT03932240
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clot Degradation at 24 Hours Post-operatively | From induction of anesthesia to 24 hours postoperatively | Blood samples were obtained from an arterial line that was required for the planned surgical procedure. Samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Clot degradation was determined by degradation kinetic study. Blood samples were collected at four time points:1) baseline sample within 24 hours of surgery and after induction of anesthesia prior to CPB; 2) after termination of CPB and transfusion of platelets and either cryoprecipitate or fibrinogen (within 1 hour of separation from bypass; 3) upon arrival to the ICU; 4) 24 hours post-operatively. The primary outcome is to examine differences in clot degradation between study arms at 24 hours post-surgery. |
| Secondary | Clot Strength | From induction of anesthesia to 24 hours postoperatively | Blood samples will be obtained from an arterial line that is required for the planned surgical procedure. They will be centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Strength will be assessed by rheology and atomic force microscopy (AFM). |
| Secondary | Clot Polymerization Kinetic | From induction of anesthesia to 24 hours postoperatively | Blood samples will be obtained from an arterial line that is required for the planned surgical procedure. They will be centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. Polymerization will be determined by thrombin-initiated turbidity/absorbency curves. |
| Secondary | Fibrin Fiber Alignment | From induction of anesthesia to 24 hours postoperatively | Clot structure is assessed by examination of images of clot fibrin fiber alignment. Quantification of clot fiber alignment was achieved through the application of an automated algorithm based on a fast Fourier transform that measures the alignment of the fibers, as well as visual inspection. A reference range has not been established for neonates, however, higher values indicate more dense clot structure. |
| Secondary | Interoperative Transfusion Requirement | During surgery (up to 6 hours) | Blood product transfusion requirements were obtained from electronic medical records. An increased transfusion requirement indicates increased interoperative bleeding, thus, lower values are preferable. |
| Secondary | Transfusion Requirements Within the First 24 Hours After Surgery | 24 hours postoperatively | Transfusion requirements within the first 24 hours of surgery were obtained from electronic medical records. |
| Secondary | Amount of Post-operative Bleeding | Up to 24 hours postoperatively | Post-operative bleeding was recorded by 24 hour chest tube output. Higher values indicate greater post-operative bleeding. |
| Secondary | Mechanical Ventilation Time | Time of extubation (up to 2 weeks) | Mechanical ventilation time was obtained from medical records. Higher values indicate increased need for mechanical ventilation. |
| Secondary | Length of ICU Stay | At discharge from ICU (typically up to 21 days) | Length of ICU stay was obtained from medical records. A shorter ICU stay indicates a favorable state of health. |
| Secondary | Length of Hospital Stay | At discharge from hospital (up to 150 days) | Length of hospital stay was obtained from medical records. A shorter hospital stay indicates a favorable state of health. |
| Secondary | Number of Adverse Events | Within seven days of surgery | Adverse events within seven days of surgery were obtained from medical records. |
| Other | Number of Events of Postoperative Thrombosis | Within the first 24 hours of surgery | The number of events of clinically significant postoperative thrombosis that required treatment were obtained from medical records. |
| Other | Fibrinogen Plasma Level | From induction of anesthesia to 24 hours postoperatively | Blood samples were obtained from an arterial line that was required for the planned surgical procedure. The samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. ELISA was used to measure coagulation factors at each time point. Normal fibrinogen plasma values are between 0.5 to 15 mcg/mL. |
| Other | Thrombin Plasma Level | From induction of anesthesia to 24 hours postoperatively | Blood samples were obtained from an arterial line that was required for the planned surgical procedure. The samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. ELISA was used to measure coagulation factors at each time point. The reference range for thrombin plasma level is 0.000313 to 0.02 mcg/mL. |
| Other | FXIII Plasma Level | From induction of anesthesia to 24 hours postoperatively | Blood samples were obtained from an arterial line that was required for the planned surgical procedure. The samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. ELISA was used to measure coagulation factors at each time point. The reference range for FXIII plasma level is 0.000469 to 0.03 mcg/mL. |
| Other | Von Willebrand Factor Plasma Level | From induction of anesthesia to 24 hours postoperatively | Blood samples were obtained from an arterial line that was required for the planned surgical procedure. The samples were centrifuged to yield platelet poor plasma (PPP), stored at -80 degrees Celsius and utilized for the clot analysis. ELISA was used to measure coagulation factors at each time point. Lower values may indicate an increased risk of excessive bleeding. |
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.
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