Trial · NCT02740335
Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.
NCT02740335, Phase 3, Completed, Octapharma; results first posted 2023-03-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk. Trials, record NCT02740335. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02740335
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.
- NCT number
- NCT02740335
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 208 participants, actual
- Lead sponsor
- Octapharma
- Conditions
- Significant Bleeding Risk
- Interventions
- Octaplex, Beriplex P/N (Kcentra)
- First posted
- 2016-04-15
- Last updated
- 2023-03-08
- Results first posted
- 2023-03-08
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hemostatic Efficacy Rating by IEAB | At the end of the surgery | Hemostatic Efficacy rated by the Independent Endpoint Adjudication Committee based on a 1 to 4 point hemostatic efficacy scale, taking into account blood loss and transfusion requirements in the context of the surgery. Hemostatic efficacy was assessed based on objective criteria in the categories 'excellent', 'good', 'moderate', or 'none'. Ratings of 'excellent' and 'good' were considered as 'effective' hemostasis, while ratings of 'moderate' and 'none' were considered as 'ineffective' hemostasis. |
| Primary | Dichotomous Hemostasis Success | At the end of surgery | To demostrate clinical non-inferiority of treatment with Octaplex to treatment with Beriplex P/N (Kcentra) with respect to hemostatic success. Effective hemostatis includes Excellent and Good ratings, while Ineffective hemostasis includes Moderate, None and missing ratings from Global hemostatic efficacy observed by IEAB |
| Secondary | Measuring of International Normalized Ratio (INR) to ≤ 1.5 | 30 minutes after the end of infusion | Number of patients with an international normalized ratio (INR) value of less or equal to 1.5 at 30 min (± 15 min) after the end of infusion. |
| Secondary | Coagulation Factor II Levels | 30 minutes after the end of infusion | Change in coagulation factor levels from baseline to after the end of infusion using the Hodges-Lehmann Estimator for median differences: o Factor II The Hodges-Lehmann Estimator is a method of robust estimation. This estimator is used to give an estimate of the difference between the values in two sets of data. If the two sets of data contain m and n data points respectively, m × n pairs of points (one from each set) can be formed and each pair gives a difference of values. The Hodges-Lehmann estimator for the difference is defined as the median of the m × n differences. |
| Secondary | Coagulation Factor VII Levels | 30 minutes after the end of infusion | Change in coagulation factor levels from baseline to after the end of infusion using the Hodges-Lehmann Estimator for median differences: o Factor VII The Hodges-Lehmann Estimator is a method of robust estimation. This estimator is used to give an estimate of the difference between the values in two sets of data. If the two sets of data contain m and n data points respectively, m × n pairs of points (one from each set) can be formed and each pair gives a difference of values. The Hodges-Lehmann estimator for the difference is defined as the median of the m × n differences. |
| Secondary | Coagulation Factor IX Levels | 30 minutes after the end of infusion | Change in coagulation factor levels from baseline to after the end of infusion using the Hodges-Lehmann Estimator for median differences: o Factor II Factor IX The Hodges-Lehmann Estimator is a method of robust estimation. This estimator is used to give an estimate of the difference between the values in two sets of data. If the two sets of data contain m and n data points respectively, m × n pairs of points (one from each set) can be formed and each pair gives a difference of values. The Hodges-Lehmann estimator for the difference is defined as the median of the m × n differences. |
| Secondary | Coagulation Factor X Levels | 30 minutes after the end of infusion | Change in coagulation factor levels from baseline to after the end of infusion using the Hodges-Lehmann Estimator for median differences: o Factor X The Hodges-Lehmann Estimator is a method of robust estimation. This estimator is used to give an estimate of the difference between the values in two sets of data. If the two sets of data contain m and n data points respectively, m × n pairs of points (one from each set) can be formed and each pair gives a difference of values. The Hodges-Lehmann estimator for the difference is defined as the median of the m × n differences. |
| Secondary | Number of Patients Requiring Red Blood Cells (RBC) | At the end of surgery | Number of patients receiving red blood cells (RBC) during the surgery |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Hemostatic Efficacy Rating by IEAB | At the end of the surgery | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Dichotomous Hemostasis Success | At the end of surgery | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Measuring of International Normalized Ratio (INR) to ≤ 1.5 | 30 minutes after the end of infusion | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Coagulation Factor II Levels | 30 minutes after the end of infusion | mg/dL | MEAN | |
| SECONDARY | Coagulation Factor VII Levels | 30 minutes after the end of infusion | mg/dL | MEAN | |
| SECONDARY | Coagulation Factor IX Levels | 30 minutes after the end of infusion | m/dL | MEAN | |
| SECONDARY | Coagulation Factor X Levels | 30 minutes after the end of infusion | mg/dL | MEAN | |
| SECONDARY | Number of Patients Requiring Red Blood Cells (RBC) | At the end of surgery | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Hemostatic Efficacy Rating by IEAB | Octaplex | Excellent - 4 | 41 | Participants | |
| Hemostatic Efficacy Rating by IEAB | Beriplex P/N (Kcentra) | Excellent - 4 | 50 | Participants | |
| Hemostatic Efficacy Rating by IEAB | Octaplex | Good - 3 | 58 | Participants | |
| Hemostatic Efficacy Rating by IEAB | Beriplex P/N (Kcentra) | Good - 3 | 47 | Participants | |
| Hemostatic Efficacy Rating by IEAB | Octaplex | Moderate - 2 | 6 | Participants | |
| Hemostatic Efficacy Rating by IEAB | Beriplex P/N (Kcentra) | Moderate - 2 | 6 | Participants | |
| Hemostatic Efficacy Rating by IEAB | Octaplex | None - 1 | 0 | Participants | |
| Hemostatic Efficacy Rating by IEAB | Beriplex P/N (Kcentra) | None - 1 | 0 | Participants | |
| Hemostatic Efficacy Rating by IEAB | Octaplex | Effective | 99 | Participants | |
| Hemostatic Efficacy Rating by IEAB | Beriplex P/N (Kcentra) | Effective | 97 | Participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Octaplex | 105 | |
| Overall Study | STARTED | Beriplex P/N (Kcentra) | 103 | |
| Overall Study | COMPLETED | Octaplex | 105 | |
| Overall Study | COMPLETED | Beriplex P/N (Kcentra) | 103 | |
| Overall Study | NOT COMPLETED | Octaplex | 0 | |
| Overall Study | NOT COMPLETED | Beriplex P/N (Kcentra) | 0 |
Source ClinicalTrials.gov
Adverse events104
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 | Anaemia | Blood and lymphatic system disorders | Octaplex | 6 | 105 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Beriplex P/N (Kcentra) | 6 | 103 | 6 |
| other | Abdominal Pain | Gastrointestinal disorders | Octaplex | 3 | 105 | 3 |
| other | Abdominal Pain | Gastrointestinal disorders | Beriplex P/N (Kcentra) | 5 | 103 | 5 |
| other | Abdominal Distension | Gastrointestinal disorders | Octaplex | 2 | 105 | 2 |
| other | Abdominal Distension | Gastrointestinal disorders | Beriplex P/N (Kcentra) | 3 | 103 | 3 |
| other | Dyschezia | Gastrointestinal disorders | Octaplex | 1 | 105 | 1 |
| other | Dyschezia | Gastrointestinal disorders | Beriplex P/N (Kcentra) | 3 | 103 | 3 |
| other | Nausea | Gastrointestinal disorders | Octaplex | 0 | 105 | 0 |
| other | Nausea | Gastrointestinal disorders | Beriplex P/N (Kcentra) | 3 | 103 | 3 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Octaplex | 5 | 105 |
| Total, all-cause mortality | Beriplex P/N (Kcentra) | 1 | 103 |
| Total, other adverse events | Octaplex | 86 | 105 |
| Total, other adverse events | Beriplex P/N (Kcentra) | 80 | 103 |
| Total, serious adverse events | Octaplex | 13 | 105 |
| Total, serious adverse events | Beriplex P/N (Kcentra) | 6 | 103 |
Source ClinicalTrials.gov
Papers13
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Octaplex vs Beriplex P/N (Kcentra): deaths from any cause | Trial comparisons |
| Octaplex vs Beriplex P/N (Kcentra): serious adverse events | 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02740335
GET https://conductscience.org/api/trials/v1/NCT02740335/results?page=2