Trial · NCT02429453
FFP Versus PCC in Intracranial Hemorrhage
NCT02429453, Not applicable, Withdrawn, University of Utah
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. FFP Versus PCC in Intracranial Hemorrhage. Trials, record NCT02429453. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02429453
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- FFP Versus PCC in Intracranial Hemorrhage
- NCT number
- NCT02429453
- Status
- Withdrawn
- Phases
- Not applicable
- Enrollment
- 0 participants, actual
- Lead sponsor
- University of Utah
- Conditions
- Intracranial Hemorrhage, Traumatic, Intracranial Hemorrhage, Spontaneous
- Interventions
- Four Factor Prothrombin Complex Concentrate, Fresh Frozen Plasma
- First posted
- 2015-04-29
- Last updated
- 2016-11-16
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rapid reversal of warfarin as measured by international normalized ratio (INR) drawn at 30 minutes after transfusion | 30 minutes after transfusion completion | INR level 30 minutes after transfusion completion of FFP or 4 factor prothrombin complex concentrate |
| Secondary | Radiographic expansion of traumatic intracerebral hemorrhage as measured by CT scan within 24 hours of presentation | 24 hours after presentation | Expansion of blood on repeat CT scan of \>10% |
| Secondary | Timing of reversal of warfarin as measured by INR drawn at 3 hours, 8 hours and 24 hours after transfusion | 3-24 hours after completion of FFP or 4 factor prothrombin complex concentrate transfusion | INR level at 3 hours, 8 hours and 24 hours after transfusion completion of FFP or prothrombin complex concentrate |
| Secondary | Thromboelastography response as measured by results of ROTEM analysis at 30 minutes and 24 hours after transfusion | 30 minutes and 24 hours after completion of FFP or 4 factor prothrombin complex concentrate transfusion | Results of ROTEM analysis at 30 minutes and 24 hours after transfusion |
| Secondary | Absolute INR reversal as measured by INR drawn 24 hours after transfusion | 24 hours after completion of FFP or 4 factor prothrombin complex concentrate transfusion | Difference between initial INR and INR 24 hours after completion of transfusion |
| Secondary | Need for operative intervention as measured by need for neurosurgical procedure during the hospitalization | During duration of hospital stay, an expected average of 1 week | Need for operative intervention during hospitalization related to initial trauma |
| Secondary | Estimated blood loss during any neurosurgical procedure | During duration of hospital stay, an expected average of 1 week | Estimated blood loss during any neurosurgical interventions during the hospitalization |
| Secondary | Further transfusion needs as measured by number of units of blood/platelet/plasma products transfused during the hospitalization | During duration of hospital stay, an expected average of 1 week | Need for blood product transfusions during hospitalization |
| Secondary | In hospital mortality | During duration of hospital stay, an expected average of 1 week | Mortality during hospital stay |
| Secondary | Total hospital cost | During duration of hospital stay, an expected average of 1 week | Total cost of hospital stay based on hospital charges |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37870112 | DERIVED |
Source PubMed
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/NCT02429453
GET https://conductscience.org/api/trials/v1/NCT02429453/registered