|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT02565836 |
|
Date of registration:
|
24/09/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Fixed-dose Activated Versus Variable-dose Inactivated Prothrombin Complex Concentrate for Warfarin-associated Major Bleed
|
|
Scientific title:
|
Reversal of Warfarin-associated Major Hemorrhage: a Multicenter, Retrospective Cohort Study of Fixed-dose Activated (FEIBA VH) Versus Variable-dose Inactivated (Kcentra) Prothrombin Complex Concentrate |
|
Date of first enrolment:
|
October 2015 |
|
Target sample size:
|
342 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02565836 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
N/A
|
|
|
Contacts
|
|
Name:
|
Robert Mokszycki, PharmD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Advocate Christ Medical Center |
|
|
Name:
|
Gary D Peksa, PharmD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Rush University Medical Center |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Pre-treatment INR lab value greater than 1.5
- Receipt of treatment with a 4-factor PCC for INR normalization due to
warfarin-associated major hemorrhage
Exclusion Criteria:
- Patients treated with a PCC for an urgent invasive procedure without active hemorrhage
- Patients treated with PCC not taking a VKA
- Unavailable pre- or post-treatment INR lab values
- Pregnant patients
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Hemorrhage
|
|
Intervention(s)
|
|
Drug: fixed-dose activated prothrombin complex concentrate
|
|
Drug: variable-dose inactivated prothrombin complex concentrate
|
|
Primary Outcome(s)
|
|
Achievement of INR less than or equal to 1.5
[Time Frame: 60 minutes]
|
|
Secondary Outcome(s)
|
|
Incidence of mortality or thrombotic events
[Time Frame: 30 days]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|