Trial · NCT03064035
Fixed Versus Variable Dosing of 4-factor Prothrombin Complex Concentrate for Emergent Warfarin Reversal
NCT03064035, Phase 4, Completed, HealthPartners Institute; results first posted 2023-07-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fixed Versus Variable Dosing of 4-factor Prothrombin Complex Concentrate for Emergent Warfarin Reversal. Trials, record NCT03064035. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03064035
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fixed Versus Variable Dosing of 4-factor Prothrombin Complex Concentrate for Emergent Warfarin Reversal
- NCT number
- NCT03064035
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 79 participants, actual
- Lead sponsor
- HealthPartners Institute
- Conditions
Acute Bleeding on Long-Term Anticoagulation Therapy, Hemorrhage, Significant Bleeding in Patients With a Coagulopathy (Prolonged Thrombin Time), Urgent Reversal of Vitamin K Antagonist (VKA) Anticoagulation
- Interventions
- 4-factor prothrombin complex concentrate (4FPCC)
- First posted
- 2017-02-24
- Last updated
- 2023-09-14
- Results first posted
- 2023-07-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Demonstrated Significant Reversal of INR Within 15 Minutes | 15 minutes | To evaluate whether fixed dose 4FPCC is acceptably comparable to variable dosing with respect to anticoagulation reversal, as defined by a targeted INR of ≤1.5 |
| Secondary | Number of Participants With a Thromboembolic Event | up to 7 days post administration of 4FPCC | Study patients will be followed post-administration of 4FPCC for thromboembolic events such as deep vein thrombosis, pulmonary embolism, ischemic stroke or transient ischemic event, or myocardial infarction. |
| Secondary | Total Cost of Dosing Strategy | Hospital Stay, Up to 6 months | Cost outcomes will be assessed for all study patients and compared by dosing assignment. Cost of treatment was assessed based on the amount of 4FPCC doses administered during admission, using the study-contemporary rate of $1.57/unit |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Demonstrated Significant Reversal of INR Within 15 Minutes | 15 minutes | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With a Thromboembolic Event | up to 7 days post administration of 4FPCC | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Total Cost of Dosing Strategy | Hospital Stay, Up to 6 months | dollars | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Demonstrated Significant Reversal of INR Within 15 Minutes | Fixed Dose 4FPCC | 21 | Participants | ||
| Number of Participants Who Demonstrated Significant Reversal of INR Within 15 Minutes | Variable Dose 4FPCC | 33 | Participants | ||
| Number of Participants With a Thromboembolic Event | Fixed Dose 4FPCC | 0 | Participants | ||
| Number of Participants With a Thromboembolic Event | Variable Dose 4FPCC | 0 | Participants | ||
| Total Cost of Dosing Strategy | Fixed Dose 4FPCC | 2524.56 | Inter-Quartile Range 2497.87 to 2551.25 | dollars | |
| Total Cost of Dosing Strategy | Variable Dose 4FPCC | 3372.36 | Inter-Quartile Range 2643.36 to 4101.36 | dollars |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fixed Dose 4FPCC | 39 | |
| Overall Study | STARTED | Variable Dose 4FPCC | 40 | |
| Overall Study | COMPLETED | Fixed Dose 4FPCC | 34 | |
| Overall Study | COMPLETED | Variable Dose 4FPCC | 37 | |
| Overall Study | NOT COMPLETED | Fixed Dose 4FPCC | 5 | |
| Overall Study | NOT COMPLETED | Variable Dose 4FPCC | 3 |
Source ClinicalTrials.gov
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 totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fixed Dose 4FPCC | 0 | 34 |
| Total, all-cause mortality | Variable Dose 4FPCC | 0 | 37 |
| Total, other adverse events | Fixed Dose 4FPCC | 0 | 34 |
| Total, other adverse events | Variable Dose 4FPCC | 0 | 37 |
| Total, serious adverse events | Fixed Dose 4FPCC | 0 | 34 |
| Total, serious adverse events | Variable Dose 4FPCC | 0 | 37 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| Fixed Dose 4FPCC vs Variable Dose 4FPCC: Number of Participants Who Demonstrated Significant Reversal of INR Within 15 Minutes | Trial comparisons |
| Fixed Dose 4FPCC vs Variable Dose 4FPCC: deaths from any cause | Trial comparisons |
| Fixed Dose 4FPCC vs Variable Dose 4FPCC: Number of Participants With a Thromboembolic Event | Trial comparisons |
| Fixed Dose 4FPCC vs Variable Dose 4FPCC: 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/NCT03064035
GET https://conductscience.org/api/trials/v1/NCT03064035/registered