Trial · NCT05523297
Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery
NCT05523297, Phase 3, Completed, Octapharma; results first posted 2025-08-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery. Trials, record NCT05523297. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05523297
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery
- NCT number
- NCT05523297
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 420 participants, actual
- Lead sponsor
- Octapharma
- Conditions
- Bleeding Cardiac Surgery Patients
- Interventions
- Octaplex, Frozen Plasma Product, Human
- First posted
- 2022-08-31
- Last updated
- 2025-08-15
- Results first posted
- 2025-08-15
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Requiring Additional Hemostatic Intervention | 60 minutes to 24 hours after first dose of IMP | Defined as 'effective' if no additional hemostatic intervention, such as administration of any systemic hemostatic agents (including platelets, cryoprecipitate, fibrinogen concentrate, activated recombinant factor VII \[rFVIIa\], other coagulation factor products or a second dose of IMP) or any hemostatic interventions (including surgical re-opening for bleeding) is required from 60 minutes to 24 hours after initiation of the first dose of IMP. |
| Secondary | Comparison of Global Hemostatic Response Based on Requirement of Additional Hemostatic Intervention and Decreased Hemoglobin Levels | 60 minutes to 24 hours after first dose of IMP | Defined as 'positive' if no additional hemostatic intervention is required and hemoglobin levels decrease by \<30% (after accounting for red cell transfusions) from 60 minutes to 24 hours after initiation of the first dose of IMP. |
| Secondary | Compare the Amount of Chest Tube Drainage Between the Octaplex and FP Groups. | 12 and 24 hours after chest closure | |
| Secondary | Compare the Incidence of Severe to Massive Bleeding Between the Octaplex and FP Groups Using a Modification of the Universal Definition of Perioperative Bleeding (UDPB). | 24 hours after surgery start, after the end of CPB and after IMP initiation | Yes or no refers to whether severe to massive bleeding was present. |
| Secondary | Compare Efficacy in Terms of the Mean Number of Total Allogeneic Blood Products (ABPs) (IMP and Non-IMP) Transfused Between the Octaplex and FP Groups. | First 24 hours after the end of CPB | |
| Secondary | Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Products Transfused Between the Octaplex and FP Groups. | First 24 hours after the end of CPB | |
| Secondary | Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. | First 24 hours and 7 days after IMP initiation | |
| Secondary | Compare Mean Number of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. | 24 hours and 7 days after start of surgery, and after the end of CPB and after IMP initiation | |
| Secondary | Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. | 24 hours and 7 days after start of surgery and after the end of CPB and after IMP initiation | |
| Secondary | Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups | 24 hours and 7 days after the start of surgery, after the end of CPB and after IMP initiation |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Requiring Additional Hemostatic Intervention | 60 minutes to 24 hours after first dose of IMP | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Comparison of Global Hemostatic Response Based on Requirement of Additional Hemostatic Intervention and Decreased Hemoglobin Levels | 60 minutes to 24 hours after first dose of IMP | Data were not available for 2 patients in the FP group due to missing hemoglobin values. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Compare the Amount of Chest Tube Drainage Between the Octaplex and FP Groups. | 12 and 24 hours after chest closure | Milliliters (mL) | MEAN | |
| SECONDARY | Compare the Incidence of Severe to Massive Bleeding Between the Octaplex and FP Groups Using a Modification of the Universal Definition of Perioperative Bleeding (UDPB). | 24 hours after surgery start, after the end of CPB and after IMP initiation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Compare Efficacy in Terms of the Mean Number of Total Allogeneic Blood Products (ABPs) (IMP and Non-IMP) Transfused Between the Octaplex and FP Groups. | First 24 hours after the end of CPB | total ABPs | MEAN | |
| SECONDARY | Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Products Transfused Between the Octaplex and FP Groups. | First 24 hours after the end of CPB | total non-IMP ABPs | MEAN | |
| SECONDARY | Compare Efficacy in Terms of the Mean Number of Total Non-IMP Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. | First 24 hours and 7 days after IMP initiation | Total non-IMP ABPs | MEAN | |
| SECONDARY | Compare Mean Number of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. | 24 hours and 7 days after start of surgery, and after the end of CPB and after IMP initiation | ABPs | MEAN | |
| SECONDARY | Compare Efficacy in Terms of the Incidence of Transfusion of Individual Allogeneic Blood Components Transfused Between the Octaplex and FP Groups. | 24 hours and 7 days after start of surgery and after the end of CPB and after IMP initiation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Compare Incidence of Administration of Non-IMP Coagulation Factor Products Between Octaplex and FP Groups | 24 hours and 7 days after the start of surgery, after the end of CPB and after IMP initiation | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group180
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Requiring Additional Hemostatic Intervention | Octaplex | Effective | 166 | Participants | |
| Number of Patients Requiring Additional Hemostatic Intervention | Frozen Plasma | Effective | 125 | Participants | |
| Number of Patients Requiring Additional Hemostatic Intervention | Octaplex | Ineffective | 47 | Participants | |
| Number of Patients Requiring Additional Hemostatic Intervention | Frozen Plasma | Ineffective | 82 | Participants | |
| Comparison of Global Hemostatic Response Based on Requirement of Additional Hemostatic Intervention and Decreased Hemoglobin Levels | Octaplex | Negative | 56 | Participants | |
| Comparison of Global Hemostatic Response Based on Requirement of Additional Hemostatic Intervention and Decreased Hemoglobin Levels | Frozen Plasma | Negative | 83 | Participants | |
| Comparison of Global Hemostatic Response Based on Requirement of Additional Hemostatic Intervention and Decreased Hemoglobin Levels | Octaplex | Positive | 157 | Participants | |
| Comparison of Global Hemostatic Response Based on Requirement of Additional Hemostatic Intervention and Decreased Hemoglobin Levels | Frozen Plasma | Positive | 122 | Participants | |
| Compare the Amount of Chest Tube Drainage Between the Octaplex and FP Groups. | Octaplex | 12 hours after chest closure | 471.20 | Standard Deviation 358.32 | Milliliters (mL) |
| Compare the Amount of Chest Tube Drainage Between the Octaplex and FP Groups. | Frozen Plasma | 12 hours after chest closure | 641.90 | Standard Deviation 465.17 | Milliliters (mL) |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Octaplex | 213 | |
| Overall Study | STARTED | Frozen Plasma | 207 | |
| Overall Study | Per-protocol Population (PP) | Octaplex | 209 | |
| Overall Study | Per-protocol Population (PP) | Frozen Plasma | 200 | |
| Overall Study | COMPLETED | Octaplex | 204 | |
| Overall Study | COMPLETED | Frozen Plasma | 198 | |
| Overall Study | NOT COMPLETED | Octaplex | 9 | |
| Overall Study | NOT COMPLETED | Frozen Plasma | 9 |
Source ClinicalTrials.gov
Adverse events642
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 | Bronchitis | Infections and infestations | Octaplex | 1 | 213 | 1 |
| other | Bronchitis | Infections and infestations | Frozen Plasma | 4 | 207 | 4 |
| other | Cellulitis | Infections and infestations | Octaplex | 2 | 213 | 2 |
| other | Cellulitis | Infections and infestations | Frozen Plasma | 1 | 207 | 1 |
| other | Clostridium difficile infection | Infections and infestations | Octaplex | 1 | 213 | 1 |
| other | Clostridium difficile infection | Infections and infestations | Frozen Plasma | 1 | 207 | 1 |
| other | COVID-19 | Infections and infestations | Octaplex | 1 | 213 | 1 |
| other | COVID-19 | Infections and infestations | Frozen Plasma | 3 | 207 | 3 |
| other | Localised infection | Infections and infestations | Octaplex | 1 | 213 | 1 |
| other | Localised infection | Infections and infestations | Frozen Plasma | 1 | 207 | 1 |
1 to 10 of 642Source ClinicalTrials.gov
See all 642 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Octaplex | 7 | 213 |
| Total, all-cause mortality | Frozen Plasma | 8 | 207 |
| Total, other adverse events | Octaplex | 206 | 213 |
| Total, other adverse events | Frozen Plasma | 201 | 207 |
| Total, serious adverse events | Octaplex | 77 | 213 |
| Total, serious adverse events | Frozen Plasma | 98 | 207 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Octaplex vs Frozen Plasma: Comparison of the Incidence of Death Between Octaplex and FP Groups | Trial comparisons |
| Octaplex vs Frozen Plasma: Comparison of Incidence of Serious Treatment-emergent Adverse Events Between Octaplex and FP Groups | Trial comparisons |
| Octaplex vs Frozen Plasma: deaths from any cause | Trial comparisons |
| Octaplex vs Frozen Plasma: 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/NCT05523297
GET https://conductscience.org/api/trials/v1/NCT05523297/registered?page=2