Trial · NCT03341156
Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation
NCT03341156, Phase 3, Terminated, University of Maryland, Baltimore
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation. Trials, record NCT03341156. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03341156
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation
- NCT number
- NCT03341156
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 14 participants, actual
- Lead sponsor
- University of Maryland, Baltimore
- Conditions
- Heart Disease End Stage, Heart Failure，Congestive
- Interventions
- Kcentra, Frozen Plasma Product, Human
- First posted
- 2017-11-14
- Last updated
- 2026-11-10
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Amount of Chest Tube Drainage | From patient out of room time until 24 hours after | Primary outcome: Amount of chest tube output in the first 24 hours |
| Secondary | Postoperative INR | 30 Minutes post-treatment (after the last dose is completed) | INR value |
| Secondary | INR Value Less Than 1.5 | 30min Post-Protamine | 30 min after the administration of study drug (Kcentra or FFP) |
| Secondary | Hemostatic Blood Products | In OR (from OR entry to OR out of room time); postoperatively (patient out of room time) to 24 hours after; from 24 hours after until 30 days post surgery or until discharge (whichever comes first) | Total hemostatic blood product use, including plasma, platelets, and cryoprecipitate. |
| Secondary | Red Blood Cell Use | Intraoperatively(from start of first intervention until start of second intervention;after 2nd intervention(post-bypass)until patient out of room time) & Postoperatively(from patient out of room time until 24 hours after;24 hours after until 30 days) | Red Blood Cell Use Intraoperatively and Postoperatively |
| Secondary | Need for Circulatory Support | 30 days post-operative or until discharge (whichever comes first) | Percentage of patients who needed circulatory support (ECMO or VAD) |
| Secondary | Mechanical Ventilation | 30 days post-operative or until discharge (whichever comes first) | Percentage of patients who needed mechanical ventilation for more than 72 hours |
| Secondary | Tracheostomy | 30 days post-operative or until discharge (whichever comes first) | Percentage of patients who needed a tracheostomy |
| Secondary | Renal Failure | 30 days post-operative or until discharge (whichever comes first) | Percentage of patients who experience renal failure requiring dialysis |
| Secondary | Sepsis | 30 days post-operative or until discharge (whichever comes first) | Percentage of patients who experienced sepsis infection morbidity consisted of sepsis syndrome, septic shock, or mediastinitis. In addition, the diagnosis of sepsis included organisms isolated from the cultures along with elevated temperature and white blood cell counts. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers16
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03341156
GET https://conductscience.org/api/trials/v1/NCT03341156/registered