Trial · NCT02557672
PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding
NCT02557672, Phase 4, Completed, Mayo Clinic; results first posted 2022-06-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding. Trials, record NCT02557672. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02557672
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding
- NCT number
- NCT02557672
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 106 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Bleeding, Blood Loss, Surgical, Cardiovascular Surgical Procedures, Prothrombin Complex Concentrates, Fresh Frozen Plasma
- Interventions
- Prothrombin complex concentrate (Human), Fresh frozen plasma (FFP)
- First posted
- 2015-09-23
- Last updated
- 2022-06-07
- Results first posted
- 2022-06-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Chest Tube Output | 24 hours | The amount of chest tube drainage output from after surgery through midnight of the next day. As measured in mL. |
| Primary | Red Blood Cell (RBC) Blood Product Transfusion | 24 hours | The number of subject's who received 0,1,2,3 or more units of RBC's transfused from completion of study drug administration though midnight of the next day. |
| Primary | Platelets Blood Product Transfusion | 24 hours | The number of subject's who received 0,1,2,3 or more units of Platelets transfused from completion of study drug administration though midnight of the next day. |
| Primary | Cryoprecipitate (Cryo) Blood Product Transfusion | 24 hours | The number of subject's who received 0,1,2,3 or more units of Cryo's transfused from completion of study drug administration though midnight of the next day. |
| Primary | Fresh Frozen Plasma (FFP) Blood Product Transfusion | 24 hours | The number of subject's who received 0,1,2,3 or more units of FFP's transfused from completion of study drug administration though midnight of the next day. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Chest Tube Output | 24 hours | 1 subject's data was not collected nor analyzed for the FFP arm | mL | MEDIAN |
| PRIMARY | Red Blood Cell (RBC) Blood Product Transfusion | 24 hours | 1 subject data was not collected nor analyzed for the FFP arm | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Platelets Blood Product Transfusion | 24 hours | 1 subject's data was not collected nor analyzed for the FFP arm | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Cryoprecipitate (Cryo) Blood Product Transfusion | 24 hours | 1 subject's data was not collected nor analyzed for the FFP arm | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Fresh Frozen Plasma (FFP) Blood Product Transfusion | 24 hours | 1 subject's data was not collected nor analyzed for the FFP arm | 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 |
|---|---|---|---|---|---|
| Chest Tube Output | Fresh Frozen Plasma | 1022 | Inter-Quartile Range 799 to 1575 | mL | |
| Chest Tube Output | Prothrombin Complex Concentrate | 937 | Inter-Quartile Range 708 to 1443 | mL | |
| Red Blood Cell (RBC) Blood Product Transfusion | Fresh Frozen Plasma | 0 units | 26 | Participants | |
| Red Blood Cell (RBC) Blood Product Transfusion | Prothrombin Complex Concentrate | 0 units | 36 | Participants | |
| Red Blood Cell (RBC) Blood Product Transfusion | Fresh Frozen Plasma | 1 unit | 11 | Participants | |
| Red Blood Cell (RBC) Blood Product Transfusion | Prothrombin Complex Concentrate | 1 unit | 8 | Participants | |
| Red Blood Cell (RBC) Blood Product Transfusion | Fresh Frozen Plasma | 2 units | 6 | Participants | |
| Red Blood Cell (RBC) Blood Product Transfusion | Prothrombin Complex Concentrate | 2 units | 5 | Participants | |
| Red Blood Cell (RBC) Blood Product Transfusion | Fresh Frozen Plasma | 3 or more units | 5 | Participants | |
| Red Blood Cell (RBC) Blood Product Transfusion | Prothrombin Complex Concentrate | 3 or more units | 2 | 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 | Fresh Frozen Plasma | 53 | |
| Overall Study | STARTED | Prothrombin Complex Concentrate | 53 | |
| Overall Study | COMPLETED | Fresh Frozen Plasma | 49 | |
| Overall Study | COMPLETED | Prothrombin Complex Concentrate | 51 | |
| Overall Study | NOT COMPLETED | Fresh Frozen Plasma | 4 | |
| Overall Study | NOT COMPLETED | Prothrombin Complex Concentrate | 2 |
Source ClinicalTrials.gov
Adverse events22
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 |
|---|---|---|---|---|---|---|
| serious | Anaphylactic or allergic reaction | Immune system disorders | Fresh Frozen Plasma | 1 | 49 | |
| serious | Anaphylactic or allergic reaction | Immune system disorders | Prothrombin Complex Concentrate | 0 | 51 | |
| serious | Thromboembolic event | Vascular disorders | Fresh Frozen Plasma | 2 | 49 | |
| serious | Thromboembolic event | Vascular disorders | Prothrombin Complex Concentrate | 1 | 51 | |
| serious | DVT | Vascular disorders | Fresh Frozen Plasma | 0 | 49 | |
| serious | DVT | Vascular disorders | Prothrombin Complex Concentrate | 1 | 51 | |
| serious | Mesenteric ischemia | Vascular disorders | Fresh Frozen Plasma | 3 | 49 | |
| serious | Mesenteric ischemia | Vascular disorders | Prothrombin Complex Concentrate | 1 | 51 | |
| serious | Stroke/TIA | Nervous system disorders | Fresh Frozen Plasma | 1 | 49 | |
| serious | Stroke/TIA | Nervous system disorders | Prothrombin Complex Concentrate | 2 | 51 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fresh Frozen Plasma | 2 | 49 |
| Total, all-cause mortality | Prothrombin Complex Concentrate | 1 | 51 |
| Total, other adverse events | Fresh Frozen Plasma | 0 | 49 |
| Total, other adverse events | Prothrombin Complex Concentrate | 0 | 51 |
| Total, serious adverse events | Fresh Frozen Plasma | 44 | 49 |
| Total, serious adverse events | Prothrombin Complex Concentrate | 45 | 51 |
Source ClinicalTrials.gov
Papers20
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 |
|---|---|
| Fresh Frozen Plasma vs Prothrombin Complex Concentrate: deaths from any cause | Trial comparisons |
| Fresh Frozen Plasma vs Prothrombin Complex Concentrate: 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/NCT02557672
GET https://conductscience.org/api/trials/v1/NCT02557672/results?page=2