Reversal of coagulopathy using prothrombin complex concentrates is associated with improved outcome compared to fresh frozen plasma in warfarin-associated intracranial hemorrhage.

Abstract

BACKGROUND:

There are no studies demonstrating that prothrombin complex concentrates (PCC) improves outcome compared FFP in patients with warfarin-associated intracranial hemorrhage.

METHODS:

A prospective, observational study was conducted of patients who received PCC (Bebulin VH), FFP, or PCC + FFP. All groups received vitamin K 10 mg IV. INR reversal (<1.4), adverse events (venous thromboembolism, myocardial infraction, pulmonary edema), major hemorrhage (new or worsened intracranial hemorrhage, anemia requiring transfusion or GI bleed), and 3-month functional outcome were compared between the groups using Chi squared and logistic regression analysis.

RESULTS:

Of 64 patients, PCC alone was used in 16 (mean dose 48 IU/kg), FFP alone in 25 (mean dose 12.5 ml/kg), and PCC + FFP in 23 (median doses 47.4 IU/kg and 11.4 ml/kg, respectively). INR correction occurred in 88, 84, and 70 %, respectively. There were no differences in time to INR correction or adverse events between the groups, but FFP alone was associated with more major hemorrhage after administration (52 %, OR 5.0, 95 % CI 1.6-15.4, P = 0.006) and PCC with less (6 %, OR 0.1, 95 % CI 0.01-0.8, P = 0.033). After adjusting for age, admission GCS, initial INR, and bleed type, the use of PCC was associated with a lower risk of death or severe disability at 3-months (adjusted OR 0.02, 95 % CI 0.001-0.8, P = 0.039), while FFP alone was associated with a higher risk (adjusted OR 51.6, 95 % CI 1.2-2163.1, P = 0.039).

CONCLUSIONS:

PCC adequately corrected INR without any increase in adverse events compared to FFP and was associated with less major hemorrhage and improved 3-month outcomes in patients with warfarin-associated intracranial hemorrhage.

• Authors: Jennifer A Frontera, Errol Gordon, Victor Zach, Maximo Jovine, Ken Uchino, Muhammad S Hussain, Louis Aledort
• Journal: Neurocritical care (Neurocrit Care) Vol. 21 Issue 3 Pg. 397-406 (Dec 2014) ISSN: 1556-0961 [Electronic] United States
• PMID: 24671832 (Publication Type: Comparative Study, Journal Article, Observational Study)

Chemical References

• Anticoagulants
• Antifibrinolytic Agents
• Blood Coagulation Factors
• Vitamin K
• prothrombin complex concentrates
• Warfarin

Topics

• Adult
• Aged
• Aged, 80 and over
• Anticoagulants (adverse effects)
• Antifibrinolytic Agents (therapeutic use)
• Blood Coagulation Disorders (chemically induced, complications, therapy)
• Blood Coagulation Factors (therapeutic use)
• Blood Component Transfusion (methods)
• Female
• Hemorrhage (chemically induced)
• Humans
• International Normalized Ratio
• Intracranial Hemorrhages (chemically induced, etiology)
• Logistic Models
• Male
• Middle Aged
• Plasma
• Prospective Studies
• Treatment Outcome
• Vitamin K (therapeutic use)
• Warfarin (adverse effects)
• Young Adult