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Trial · NCT01779921

Registered outcomes23

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

ListOutcomeTime frameDescription
PrimaryTreatment of bleeding episodes at clinic/hospital: Treatment efficacy evaluation for each treatment modality: excellent, effective, partly effective, ineffective, or not evaluableEvaluated at 6 hours
PrimaryTreatment of bleeding episodes at clinic/hospital: Treatment efficacy evaluation for each treatment modality: excellent, effective, partly effective, ineffective, or not evaluableEvaluated after 30 days
PrimaryTreatment of bleeding episodes at clinic/hospital: Time to achieve arrest of bleedingTime to achieve arrest of bleeding
PrimaryTreatment of bleeding episodes at clinic/hospital: Number of re-bleeding episodesWithin 5 days after first product administration
PrimaryTreatment of bleeding episodes at home: Treatment efficacy evaluation for each treatment modality: excellent, effective, partly effective, ineffective, or not evaluableEvaluated at 6 hours
PrimaryTreatment of bleeding episodes at home: Time to achieve arrest of bleedingTime to achieve arrest of bleeding
PrimaryTreatment efficacy (of first and/or second treatment modality) evaluated after surgery: good, partially effective, not evaluable, or ineffectiveAfter surgery
PrimaryTreatment efficacy (of first and/or second treatment modality) evaluated after surgery: good, partially effective, not evaluable, or ineffectiveEvaluated after 30 days
PrimaryEstimated blood loss volumeDuring surgery/delivery
PrimaryNumber of red blood cell units administeredDuring surgery
PrimaryNumber of days spent in hospitalUntil last data collection (20 Jan 2012)
PrimaryNumber of re-bleeding episodes (associated with the surgery)Within 5 days after surgery
PrimaryProphylactic treatment efficacy evaluation: excellent, excellent, partially effective, or effective30 days after first prophylaxis dose
SecondaryNumber of bleeding episodes during prophylaxis per yearUp to one year
SecondaryNumber of intensive care unit (ICU) and/or the number of ward daysAfter first haemostatic product administration until day 30
SecondaryMortalityWithin a 30-day (follow-up) period
SecondaryChanges in laboratory parameters (prothombin time/international normalized ratio, activated partial thromboplastin time, FVII clotting activity, platelet count, fibrinogen)Prior to dosing
SecondaryChanges in laboratory parameters (prothombin time/international normalized ratio, activated partial thromboplastin time, FVII clotting activity, platelet count, fibrinogen)After 15 minutes
SecondaryChanges in laboratory parameters (prothombin time/international normalized ratio, activated partial thromboplastin time, FVII clotting activity, platelet count, fibrinogen)After 30 days
SecondaryPresence of and/or de novo appearance of inhibiting antibodies to FVIIPrior to dosing

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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