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Trial · NCT02281500

Results by group27

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Area Under the Plasma Fibrinogen Concentration-time Curve (AUC) From Time Zero to 14 Days (AUC0-14days) of FIB Grifols Determined by Clauss Method, Dose Normalized to 70 mg/kg and Corrected for Baseline Concentration
FIB Grifols 70 mg/kg Body Weight145.67Standard Deviation 43.441hour*grams per liter (h*g/L)
Area Under the Plasma Fibrinogen Concentration-time Curve (AUC) From Time Zero to 14 Days (AUC0-14days) of FIB Grifols Determined by Enzyme-Linked Immunosorbent Assay (ELISA) Method, Dose Normalized to 70 mg/kg and Corrected for Baseline Concentration
FIB Grifols 70 mg/kg Body Weight186.63Standard Deviation 95.734hour*milligram per milliliter (h*mg/mL)
AUC From Time Zero to Infinite Time (AUC0-infinity) of FIB Grifols Determined by Clauss Method, Dose Normalized to 70 mg/kg and Corrected for Baseline ConcentrationFIB Grifols 70 mg/kg Body Weight166.78Standard Deviation 54.081hours*gram per liter (h*g/L)
AUC From Time Zero to Infinite Time (AUC0-infinity) of FIB Grifols Determined by ELISA Method, Dose Normalized to 70 mg/kg and Corrected for Baseline ConcentrationFIB Grifols 70 mg/kg Body Weight242.94Standard Deviation 117.567h*mg/mL
Maximum Observed Peak Plasma Fibrinogen Concentration (Cmax) of FIB Grifols Determined by Clauss Method, Dose Normalized to 70 mg/kg and Corrected for Baseline ConcentrationFIB Grifols 70 mg/kg Body Weight1.99Standard Deviation 0.404gram per liter (g/L)
Maximum Observed Peak Plasma Fibrinogen Concentration (Cmax) of FIB Grifols Determined by ELISA Method, Dose Normalized to 70 mg/kg and Corrected for Baseline ConcentrationFIB Grifols 70 mg/kg Body Weight2.88Standard Deviation 0.859milligram per milliliter (mg/mL)
Time to Reach Maximum Plasma Fibrinogen Concentration (Tmax) of FIB Grifols Determined by Clauss Method, Dose Normalized to 70 mg/kg and Corrected for Baseline ConcentrationFIB Grifols 70 mg/kg Body Weight1.40Full Range 1.0 to 24.5hour (h)
Time to Reach Maximum Plasma Fibrinogen Concentration (Tmax) of FIB Grifols Determined by ELISA MethodFIB Grifols 70 mg/kg Body Weight1.80Full Range 1.1 to 24.5hour (h)
Apparent Terminal Half-life (t1/2) of FIB Grifols Determined by Clauss Method, Dose Normalized to 70 mg/kg and Corrected for Baseline ConcentrationFIB Grifols 70 mg/kg Body Weight76.94Standard Deviation 20.215hour (h)
Apparent Terminal Half-life (t1/2) of FIB Grifols Determined by ELISA Method, Dose Normalized to 70 mg/kg and Corrected for Baseline ConcentrationFIB Grifols 70 mg/kg Body Weight66.92Standard Deviation 16.789hour (h)
Mean Residence Time (MRT) of FIB Grifols Determined by Clauss Method, Dose Normalized to 70 mg/kg and Corrected for Baseline ConcentrationFIB Grifols 70 mg/kg Body Weight72.67Standard Deviation 12.185hour (h)
Mean Residence Time (MRT) of FIB Grifols Assessed Determined by ELISA Method, Dose Normalized to 70 mg/kg and Corrected for Baseline ConcentrationFIB Grifols 70 mg/kg Body Weight62.64Standard Deviation 19.142hour (h)
Volume of Distribution (Vd) of FIB Grifols Determined by Clauss Method, Dose Normalized to 70 mg/kg and Corrected for Baseline ConcentrationFIB Grifols 70 mg/kg Body Weight47.932Standard Deviation 7.5997milliliter per kilogram (mL/kg)
Volume of Distribution (Vd) of FIB Grifols Determined by ELISA Method, Dose Normalized to 70 mg/kg and Corrected for Baseline ConcentrationFIB Grifols 70 mg/kg Body Weight31.264Standard Deviation 10.9702mL/kg
Clearance (Cl) of FIB Grifols Determined By Clauss Method, Dose Normalized to 70 mg/kg and Corrected for Baseline ConcentrationFIB Grifols 70 mg/kg Body Weight0.454Standard Deviation 0.1216mL per hour per kilogram (mL/h/kg)
Clearance (Cl) of FIB Grifols Determined By ELISA Method, Dose Normalized to 70 mg/kg and Corrected for Baseline ConcentrationFIB Grifols 70 mg/kg Body Weight0.341Standard Deviation 0.1360mL/h/kg
In Vivo Recovery (IVR) of FIB Grifols Determined by Clauss MethodFIB Grifols 70 mg/kg Body Weight2.380Standard Deviation 0.6689milligram per deciliter (mg/dL)/ (mg/kg)
In Vivo Recovery (IVR) of FIB Grifols Determined by ELISA MethodFIB Grifols 70 mg/kg Body Weight3.474Standard Deviation 1.3607(mg/dL)/(mg/kg)
Mean Change on Maximum Clot Firmness (MCF) From Baseline to 1-hour Post-infusionFIB Grifols 70 mg/kg Body Weight10.71Standard Deviation 4.122millimeter (mm)
Mean Change in Clotting Time (CT) From Baseline to 1-hour Post-infusionFIB Grifols 70 mg/kg Body Weight-3462.0Standard Deviation NASeconds (sec)

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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