Trial · NCT00803101
An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure
NCT00803101, Phase 3, Completed, CSL Behring; results first posted 2014-02-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure. Trials, record NCT00803101. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00803101
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure
- NCT number
- NCT00803101
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 176 participants, actual
- Lead sponsor
- CSL Behring
- Conditions
- Reversal of Coagulopathy
- Interventions
- Beriplex® P/N (Kcentra), Fresh frozen plasma
- First posted
- 2008-12-05
- Last updated
- 2015-04-06
- Other registries' IDs
- eudract:2007-007862-39
- Results first posted
- 2014-02-25
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Hemostatic Efficacy During Surgery | From the start of infusion until the end of surgery | Hemostatic efficacy was rated as excellent, good, or poor/none, based on prespecified definitions. Hemostatic efficacy was the binary endpoint of effective or non-effective hemostasis, where 'effective' was a hemostatic efficacy rating of "excellent" or "good," and 'non-effective' was a hemostatic efficacy rating of "poor/none". |
| Primary | Percentage of Participants Who Had a Rapid Decrease of the INR | 30 minutes after the end of infusion | A rapid decrease of the INR was defined as an INR ≤ 1.3 at 30 minutes after the end of infusion. The INR is a standard way to describe the time it takes for blood to clot; an INR range of 0.8 to 1.2 is considered normal for a healthy person who is not using oral anticoagulant therapy. |
| Secondary | Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S | From pre-infusion until 24 h after the start of infusion | Plasma levels are presented as the percentage of normal at pre-infusion and 30 min and 24 h after the start of infusion. The plasma level assay results are reported as a potency relative to a standard, where 100% is considered to be normal. |
| Secondary | Transfusion of Packed Red Blood Cells (PRBCs) or Whole Blood | From the start of surgery until 24 h after the start of surgery | The total units of transfused PRBCs or whole blood |
| Secondary | Percentage of Participants With INR Correction at Various Times After the Start of Infusion | From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion | The time taken from the start of infusion to INR correction (defined as an INR ≤ 1.3) was recorded. The percentage of participants with INR correction was calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion. |
| Secondary | Percentage of Participants Who Received Red Blood Cells | From the start of surgery until 24 h after the start of surgery | Red blood cells were PRBCs and whole blood |
| Secondary | Overall Treatment-emergent Adverse Events (TEAEs) | From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs | Number of participants with TEAEs. TEAEs were defined as adverse events that developed or worsened following exposure to investigational medicinal product. Treatment-related TEAEs were events whose relationship to study treatment was related, probably related, or possibly related in the opinion of the investigator. Treatment emergent adverse events with missing relationship were considered related to treatment. Serious TEAEs were treatment-emergent serious adverse events (SAEs). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Hemostatic Efficacy During Surgery | From the start of infusion until the end of surgery | The Intention-to-Treat Efficacy ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Had a Rapid Decrease of the INR | 30 minutes after the end of infusion | The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | percentage of participants | NUMBER |
| SECONDARY | Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S | From pre-infusion until 24 h after the start of infusion | The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | percentage of normal | MEAN |
| SECONDARY | Transfusion of Packed Red Blood Cells (PRBCs) or Whole Blood | From the start of surgery until 24 h after the start of surgery | The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | units of PRBCs or whole blood | MEAN |
| SECONDARY | Percentage of Participants With INR Correction at Various Times After the Start of Infusion | From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion | The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Received Red Blood Cells | From the start of surgery until 24 h after the start of surgery | The ITT-E population included all randomized participants who had received any study product, underwent the intended surgical procedure, and had an international normalized ratio INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'. | percentage of participants | NUMBER |
| SECONDARY | Overall Treatment-emergent Adverse Events (TEAEs) | From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs | The Intention-to-Treat Safety (ITT-S) population included all participants who were randomized and who had received any portion of study product. Participants in the ITT-S population were analyzed 'as treated'. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group64
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Hemostatic Efficacy During Surgery | Beriplex® P/N | 89.7 | 95% Confidence Interval 83.3 to 96.1 | percentage of participants | |
| Percentage of Participants Achieving Hemostatic Efficacy During Surgery | Fresh Frozen Plasma | 75.3 | 95% Confidence Interval 65.9 to 84.7 | percentage of participants | |
| Percentage of Participants Who Had a Rapid Decrease of the INR | Beriplex® P/N | 55.2 | 95% Confidence Interval 44.7 to 65.6 | percentage of participants | |
| Percentage of Participants Who Had a Rapid Decrease of the INR | Fresh Frozen Plasma | 9.9 | 95% Confidence Interval 3.4 to 16.4 | percentage of participants | |
| Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S | Beriplex® P/N | Factor II, pre-infusion (n = 85; 79) | 32.0 | Standard Deviation 19.93 | percentage of normal |
| Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S | Fresh Frozen Plasma | Factor II, pre-infusion (n = 85; 79) | 34.8 | Standard Deviation 26.19 | percentage of normal |
| Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S | Beriplex® P/N | Factor II, 0.5 h after infusion start (n = 71; 73) | 84.5 | Standard Deviation 20.92 | percentage of normal |
| Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S | Fresh Frozen Plasma | Factor II, 0.5 h after infusion start (n = 71; 73) | 42.5 | Standard Deviation 25.71 | percentage of normal |
| Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S | Beriplex® P/N | Factor II, 24 h after infusion start (n = 81; 74) | 81.4 | Standard Deviation 24.83 | percentage of normal |
| Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S | Fresh Frozen Plasma | Factor II, 24 h after infusion start (n = 81; 74) | 65.6 | Standard Deviation 23.68 | percentage of normal |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Beriplex® P/N | 88 | |
| Overall Study | STARTED | Fresh Frozen Plasma | 88 | |
| Overall Study | COMPLETED | Beriplex® P/N | 70 | |
| Overall Study | COMPLETED | Fresh Frozen Plasma | 66 | |
| Overall Study | NOT COMPLETED | Beriplex® P/N | 18 | |
| Overall Study | NOT COMPLETED | Fresh Frozen Plasma | 22 |
Source ClinicalTrials.gov
Adverse events204
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Beriplex® P/N | 10 | 88 | 10 |
| other | Constipation | Gastrointestinal disorders | Fresh Frozen Plasma | 4 | 88 | 4 |
| other | Nausea | Gastrointestinal disorders | Beriplex® P/N | 7 | 88 | 7 |
| other | Nausea | Gastrointestinal disorders | Fresh Frozen Plasma | 4 | 88 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Beriplex® P/N | 3 | 88 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Fresh Frozen Plasma | 3 | 88 | 3 |
| other | Dysphagia | Gastrointestinal disorders | Beriplex® P/N | 1 | 88 | 1 |
| other | Dysphagia | Gastrointestinal disorders | Fresh Frozen Plasma | 2 | 88 | 2 |
| other | Vomiting | Gastrointestinal disorders | Beriplex® P/N | 2 | 88 | 2 |
| other | Vomiting | Gastrointestinal disorders | Fresh Frozen Plasma | 1 | 88 | 1 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Beriplex® P/N | ||
| Total, all-cause mortality | Fresh Frozen Plasma | ||
| Total, other adverse events | Beriplex® P/N | 41 | 88 |
| Total, other adverse events | Fresh Frozen Plasma | 44 | 88 |
| Total, serious adverse events | Beriplex® P/N | 22 | 88 |
| Total, serious adverse events | Fresh Frozen Plasma | 23 | 88 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Beriplex® P/N vs Fresh Frozen Plasma: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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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