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Trial · NCT03341156

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryAmount of Chest Tube DrainageFrom patient out of room time until 24 hours afterPrimary outcome: Amount of chest tube output in the first 24 hours
SecondaryPostoperative INR30 Minutes post-treatment (after the last dose is completed)INR value
SecondaryINR Value Less Than 1.530min Post-Protamine30 min after the administration of study drug (Kcentra or FFP)
SecondaryHemostatic Blood ProductsIn OR (from OR entry to OR out of room time); postoperatively (patient out of room time) to 24 hours after; from 24 hours after until 30 days post surgery or until discharge (whichever comes first)Total hemostatic blood product use, including plasma, platelets, and cryoprecipitate.
SecondaryRed Blood Cell Use
Intraoperatively(from start of first intervention until start of second intervention;after 2nd intervention(post-bypass)until patient out of room time) & Postoperatively(from patient out of room time until 24 hours after;24 hours after until 30 days)
Red Blood Cell Use Intraoperatively and Postoperatively
SecondaryNeed for Circulatory Support30 days post-operative or until discharge (whichever comes first)Percentage of patients who needed circulatory support (ECMO or VAD)
SecondaryMechanical Ventilation30 days post-operative or until discharge (whichever comes first)Percentage of patients who needed mechanical ventilation for more than 72 hours
SecondaryTracheostomy30 days post-operative or until discharge (whichever comes first)Percentage of patients who needed a tracheostomy
SecondaryRenal Failure30 days post-operative or until discharge (whichever comes first)Percentage of patients who experience renal failure requiring dialysis
SecondarySepsis30 days post-operative or until discharge (whichever comes first)
Percentage of patients who experienced sepsis infection morbidity consisted of sepsis syndrome, septic shock, or mediastinitis. In addition, the diagnosis of sepsis included organisms isolated from the cultures along with elevated temperature and white blood cell counts.
SecondaryDeath30 days post-operative or until discharge (whichever comes first)Percentage of patients who died
SecondaryStroke or Postoperative Neurological Dysfunction30 days post-operative or until discharge (whichever comes first)Percentage of patients who experienced a stroke or postoperative neurological dysfunction (seizures, delirium, unconsciousness, encephalopathy)
SecondaryGastrointestinal Complication Requiring Bowel Resection30 days post-operative or until discharge (whichever comes first)Percentage of patients who experienced gastrointestinal complications requiring bowel resection
SecondaryPeripheral Vascular Complication30 days post-operative or until discharge (whichever comes first)Percentage of patients who experience peripheral vascular complications requiring surgery (thrombectomy, bypass, and amputations)
SecondaryDeep Vein Thrombosis and Pulmonary Thromboembolism30 days post-operative or until discharge (whichever comes first)Percentage of patients who develop a deep vein thrombosis and/ or pulmonary thromboembolism
SecondaryPlasma Coagulation Factor LevelsAt baseline, post-bypass/pre-protamine, 30 minutes post-protamine, 12-24 hours post treatmentPlasma coagulator factor levels will be analyzed via blood laboratory tests
SecondaryThrombin Generation AssayAt baseline, post-bypass/pre-protamine, 30 minutes post-protamine, 12-24 hours post treatmentThrombin Generation assay will be analyzed via blood laboratory tests
SecondarySurgical Re-exploration30 days post-operative or until discharge (whichever comes first)Surgical Re-Exploration that is related to heart transplant surgery

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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