Prothrombin complex concentrates: Difference between revisions
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==General== | ==General== | ||
*Type: Hemostatics, blood components | *Type: Hemostatics, [[blood components]] | ||
*Dosage Forms:lypophilized concentrate for reconstitution 500u/vial and 1000u/vial | *Dosage Forms:lypophilized concentrate for reconstitution 500u/vial and 1000u/vial | ||
*Common Trade Names: Kcentra | *Common Trade Names: Kcentra | ||
*3 factor PCC (Factors II, IX, and X), would need to supplement with factor VII for reversal if using 3 factor PCC | |||
**Approved for treatment of hemophilia B (factor IX deficiency) | |||
*4 factor PCC (Factors II, VII, IX, and X) | |||
**Approved for reversal of vitamin K antagonists | |||
*Does not require thawing or ABO-compatibility testing, and less risk for volume overload (in contrast to [[Fresh frozen plasma|FFP]]) <ref>Clinton J. Coil. “Transfusion Therapy.” Tintinalli’s Emergency Medicine: a Comprehensive Study Guide, by Judith E. Tintinalli et al., 8th ed., McGraw-Hill Education, 2016.</ref> | |||
==Adult Dosing== | ==Adult Dosing== | ||
*Based on pretreatment INR, units based on factor 9 content | *Based on pretreatment INR, units based on factor 9 content | ||
** | **INR 2-4: 25units/kg, not to exceed 2500 units | ||
** | **INR 4-6: 35units/kg, not to exceed 3500 units | ||
**INR>6: 50units/kg, not to exceed 5000 units | **INR >6: 50units/kg, not to exceed 5000 units | ||
*Consider rechecking INR after 15 minutes to determine need for redosing | |||
*Fixed dose Kcentra equivalent to weight based (while being easier to administer and less expensive)<ref>Bitonti MT et al. Prospective Evaluation of a Fixed-Dose 4-Factor Prothrombin Complex Concentrate Protocol for Urgent Vitamin K Antagonist Reversal. J Emerg Med 2019;X(XX). https://doi.org/10.1016/j.jemermed.2019.10.013</ref><ref> Fixed-Dose PCC Dosing for Vitamin K Antagonist-Associated Hemorrhage: Is it Safe and Effective? by Kayvan Moussavi http://www.emdocs.net/fixed-dose-pcc-dosing-for-vitamin-k-antagonist-associated-hemorrhage-is-it-safe-and-effective/</ref> | |||
**Baseline INR ≤7.5 and ≤100 kg: 1500 units of Kcentra | |||
**Baseline INR >7.5 or >100 kg: 2000 units of Kcentra | |||
==Pediatric Dosing== | ==Pediatric Dosing== | ||
Safety and efficacy not established | *Safety and efficacy not established | ||
==Special Populations== | ==Special Populations== | ||
| Line 24: | Line 34: | ||
==Contraindications== | ==Contraindications== | ||
*Allergy to class/drug | *Allergy to class/drug | ||
*DIC | *[[DIC]] | ||
*known HIT (Heparin induced thrombocytopenia) | *known [[HIT]] (Heparin induced thrombocytopenia) | ||
===Serious=== | ===Serious=== | ||
*thromboembolism | *Patients receiving PCC for reversal of a vitamin K antagonist ([[Warfarin]]) due to life-threatening bleeding have a rate of thromboembolism which is similar to the rate in patients who receive [[Fresh frozen plasma]] (7.3% v 7.1%).<ref>Milling, TJ Jr et al. Thromboembolic events after vitamin K antagonist reversal with 4-factor prothrombin complex concentrate: exploratory analyses of two randomized, plasma-controlled studies. Ann Emerg Med. 2016 Jan;67(1):96-105. PMID: 26094105</ref> | ||
===Common=== | ===Common=== | ||
* | *Thromboembolic events | ||
* | *[[Headache]] | ||
* | *[[Hypotension]] (4.9%) | ||
* | *[[Nausea/vomiting]] | ||
* | *Arthralgia | ||
*ICH (2.9%) | *[[ICH]] (2.9%) | ||
* | *Mental status change | ||
* | *Hypertension (2.9%) | ||
==Pharmacology== | ==Pharmacology== | ||
*Half-life: | *Half-life: 4-60 hours, depending on clotting factor | ||
*Metabolism: | *Metabolism: | ||
*Excretion: | *Excretion: | ||
*Mechanism of Action: | *Mechanism of Action: 4 factor PCC contains factors II, VII, XI, X, protein C and S | ||
==See Also== | ==See Also== | ||
*[[Blood | *[[Anticoagulant reversal for life-threatening bleeds]] | ||
*[[ | *[[Anti-platelet agent reversal]] | ||
*[[Blood products]] | |||
*[[Warfarin reversal]] | |||
== | ==References== | ||
<references/> | <references/> | ||
[[Category: | |||
[[Category:Pharmacology]] | |||
[[Category:Heme/Onc]] | |||
Latest revision as of 21:04, 22 December 2020
General
- Type: Hemostatics, blood components
- Dosage Forms:lypophilized concentrate for reconstitution 500u/vial and 1000u/vial
- Common Trade Names: Kcentra
- 3 factor PCC (Factors II, IX, and X), would need to supplement with factor VII for reversal if using 3 factor PCC
- Approved for treatment of hemophilia B (factor IX deficiency)
- 4 factor PCC (Factors II, VII, IX, and X)
- Approved for reversal of vitamin K antagonists
- Does not require thawing or ABO-compatibility testing, and less risk for volume overload (in contrast to FFP) [1]
Adult Dosing
- Based on pretreatment INR, units based on factor 9 content
- INR 2-4: 25units/kg, not to exceed 2500 units
- INR 4-6: 35units/kg, not to exceed 3500 units
- INR >6: 50units/kg, not to exceed 5000 units
- Consider rechecking INR after 15 minutes to determine need for redosing
- Fixed dose Kcentra equivalent to weight based (while being easier to administer and less expensive)[2][3]
- Baseline INR ≤7.5 and ≤100 kg: 1500 units of Kcentra
- Baseline INR >7.5 or >100 kg: 2000 units of Kcentra
Pediatric Dosing
- Safety and efficacy not established
Special Populations
- Pregnancy Rating: C
- Lactation: Unknown, breast feeding not advised
- Renal Dosing
- Adult-N/A
- Pediatric-N/A
- Hepatic Dosing
- Adult-N/A
- Pediatric-N/A
Contraindications
Serious
- Patients receiving PCC for reversal of a vitamin K antagonist (Warfarin) due to life-threatening bleeding have a rate of thromboembolism which is similar to the rate in patients who receive Fresh frozen plasma (7.3% v 7.1%).[4]
Common
- Thromboembolic events
- Headache
- Hypotension (4.9%)
- Nausea/vomiting
- Arthralgia
- ICH (2.9%)
- Mental status change
- Hypertension (2.9%)
Pharmacology
- Half-life: 4-60 hours, depending on clotting factor
- Metabolism:
- Excretion:
- Mechanism of Action: 4 factor PCC contains factors II, VII, XI, X, protein C and S
See Also
- Anticoagulant reversal for life-threatening bleeds
- Anti-platelet agent reversal
- Blood products
- Warfarin reversal
References
- ↑ Clinton J. Coil. “Transfusion Therapy.” Tintinalli’s Emergency Medicine: a Comprehensive Study Guide, by Judith E. Tintinalli et al., 8th ed., McGraw-Hill Education, 2016.
- ↑ Bitonti MT et al. Prospective Evaluation of a Fixed-Dose 4-Factor Prothrombin Complex Concentrate Protocol for Urgent Vitamin K Antagonist Reversal. J Emerg Med 2019;X(XX). https://doi.org/10.1016/j.jemermed.2019.10.013
- ↑ Fixed-Dose PCC Dosing for Vitamin K Antagonist-Associated Hemorrhage: Is it Safe and Effective? by Kayvan Moussavi http://www.emdocs.net/fixed-dose-pcc-dosing-for-vitamin-k-antagonist-associated-hemorrhage-is-it-safe-and-effective/
- ↑ Milling, TJ Jr et al. Thromboembolic events after vitamin K antagonist reversal with 4-factor prothrombin complex concentrate: exploratory analyses of two randomized, plasma-controlled studies. Ann Emerg Med. 2016 Jan;67(1):96-105. PMID: 26094105