Fixed-dose Activated Versus Variable-dose Inactivated Prothrombin Complex Concentrate for Warfarin-associated Major Bleed

NCT02565836 | Completed

• 1 other identifier: 15092404
• Study Type: observational
• Target: 342
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to assess a fixed-dose regimen of activated prothrombin complex concentrate (FEIBA VH, Baxter) versus the variable, manufacturer recommended, dose regimen of inactivated prothrombin complex concentrate (Kcentra, CSL Behring) for reversal of warfarin-associated major hemorrhage.

Conditions

Hemorrhage

Keywords

Vitamin K 1; prothrombin complex concentrates; warfarin

Outcome Measures

Primary Outcomes (1)

• Achievement of INR less than or equal to 1.5

  The number of patients achieving a goal INR of less than or equal to 1.5 within 60 minutes following administration of 4-factor fixed-dose aPCC (FEIBA VH) versus variable-dose inactivated PCC (Kcentra) for reversal of warfarin-associated major hemorrhage.

  60 minutes

Secondary Outcomes (1)

• Incidence of mortality or thrombotic events

  30 days

Study Arms (2)

fixed-dose aPCC

Patients receiving fixed-dose activated prothrombin complex concentrate (FEIBA VH) for reversal of warfarin-associated major hemorrhage.

Drug: fixed-dose activated prothrombin complex concentrate

variable-dose PCC

Patients receiving vairable-dose inactivated prothrombin complex concentrate (Kcentra) for reversal of warfarin-associated major hemorrhage.

Drug: variable-dose inactivated prothrombin complex concentrate

Interventions

fixed-dose activated prothrombin complex concentrate DRUG

FEIBA VH 500 units IV one time for INR less than 5. FEIBA VH 1000 units IV one time for INR greater than 5. Check INR after infusion and may repeat dose if INR still elevated

Also known as: FEIBA, FEIBA VH

fixed-dose aPCC

variable-dose inactivated prothrombin complex concentrate DRUG

Kcentra 25 units/kg IV one time for INR less than 4. Kcentra 35 units/kg IV one-time for INR 4 to 6. Kcentra 50 units/kg IV one-time for INR greater than 6. Check INR after infusion and may repeat dose if INR still elevated.

Also known as: Kcentra

variable-dose PCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients administered a prothrombin complex concentrate as part of routine care for INR normalization due to a major bleed will be assessed for inclusion.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead
• Wake Forest University Health Sciences: collaborator

Related Publications (5)

• Junagade P, Grace R, Gover P. Fixed dose prothrombin complex concentrate for the reversal of oral anticoagulation therapy. Hematology. 2007 Oct;12(5):439-40. doi: 10.1080/10245330701448529.

  PMID: 17852462 BACKGROUND

• Wojcik C, Schymik ML, Cure EG. Activated prothrombin complex concentrate factor VIII inhibitor bypassing activity (FEIBA) for the reversal of warfarin-induced coagulopathy. Int J Emerg Med. 2009 Nov 26;2(4):217-25. doi: 10.1007/s12245-009-0125-8.

  PMID: 20436891 BACKGROUND

• Khorsand N, Veeger NJ, van Hest RM, Ypma PF, Heidt J, Meijer K. An observational, prospective, two-cohort comparison of a fixed versus variable dosing strategy of prothrombin complex concentrate to counteract vitamin K antagonists in 240 bleeding emergencies. Haematologica. 2012 Oct;97(10):1501-6. doi: 10.3324/haematol.2012.063701. Epub 2012 Apr 4.

  PMID: 22491734 BACKGROUND

• Stewart WS, Pettit H. Experiences with an activated 4-factor prothrombin complex concentrate (FEIBA) for reversal of warfarin-related bleeding. Am J Emerg Med. 2013 Aug;31(8):1251-4. doi: 10.1016/j.ajem.2013.05.008. Epub 2013 Jun 10.

  PMID: 23763937 BACKGROUND

• Sarode R, Milling TJ Jr, Refaai MA, Mangione A, Schneider A, Durn BL, Goldstein JN. Efficacy and safety of a 4-factor prothrombin complex concentrate in patients on vitamin K antagonists presenting with major bleeding: a randomized, plasma-controlled, phase IIIb study. Circulation. 2013 Sep 10;128(11):1234-43. doi: 10.1161/CIRCULATIONAHA.113.002283. Epub 2013 Aug 9.

  PMID: 23935011 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Interventions

anti-inhibitor coagulant complex

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gary D Peksa, PharmD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Robert Mokszycki, PharmD

  advocate christ medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: October 1, 2015
• Study Start: October 1, 2015
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: October 25, 2017

Record last verified: 2017-10