Trial · NCT02540434
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 | Intraoperative Blood Transfusion Total | Procedure length, the average for participants is approximately 6 hours | The combined number of allogeneic blood products (platelets + Fresh Frozen Plasma (FFP) + RBCs) administered to subjects intraoperatively after study intervention. |
| Secondary | 24-hour Blood Transfusion Total | 24 hours | Number of units of RBC, Platelets, cryoprecipitate, FFP, or other blood products administered to subjects receiving study product within the first 24 hours after procedure end |
| Secondary | Fibrinogen Repletion | Procedure length, the average for participants is approximately 6 hours | Fibrinogen repletion as measured by ROTEM FIBTEM \>10mm after study product administration. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment |
| Secondary | Incidence of Zero Transfusions | 24 hours | Number of patients who receive no allogeneic blood transfusions following study product administration and first 24 hours after procedure end. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment |
| Secondary | Correction of Microvascular Bleeding | ~30 min intraoperatively | Difference in surgeon's assessment of microvascular bleeding from approximately 15 minutes before to approximately 15 minutes after administration of study medication. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment |
| Secondary | CTICU Length of Stay | Length of Hospital Stay, the average for participants is approximately 7 days | Number of days subject spends in cardiothoracic intensive care unit from procedure end to hospital discharge. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment |
| Secondary | Hospital Length of Stay | Length of Hospital Stay, the average for participants is approximately 7 days | Number of days subject spends in the hospital from procedure end to hospital discharge. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment. |
| Secondary | Thrombosis and Transfusion Reactions | Length of Hospital Stay, the average for participants is approximately 7 days | Incidence of intraoperative or postoperative (during hospital admission only) thrombosis (symptomatic only) and transfusion reactions from procedure to hospital discharge. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment. |
| Secondary | Infection and Respiratory Failure | Length of Hospital Stay, the average for participants is approximately 7 days | Incidence of any infection or respiratory failure from procedure end to hospital discharge. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment. |
| Secondary | Blood Loss | Length of Hospital Stay, the average for participants is approximately 7 days, | Quantity of intraoperative and postoperative blood loss as recorded in the anesthesia record and in chest tube outputs (blood drainage volume). Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment. |
| Secondary | Incidence of Re-exploration | Length of Hospital Stay, the average for participants is approximately 7 days | Incidence of subjects requiring a return to the OR for re-exploration. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment. |
| Secondary | Mortality Rate | Length of Hospital Stay, the average for participants is approximately 7 days | Rate of hospital death during initial hospital admission. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment |
| Secondary | Correlation of Laboratory and ROTEM Data | Procedure length, the average for participants is approximately 6 hours | Correlation of fibrinogen, von Willebrand Factor (vWF), and factor VIII levels measured in traditional lab with intraoperative ROTEM parameters. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment. |
| Secondary | Time to Product Administration | Procedure length, the average for participants is approximately 6 hours | Time from request to administration of study product. Trial terminated prior to the collection of this data due to feasibility issues preventing completion of recruitment. |
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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