Subgroup Analysis for Mode of Reversal Treatment FFP vs PCC

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The German-wide Multicenter Analysis of Oral Anticoagulation-associated Intracerebral Hemorrhage (RETRACE) investigators performed this study on behalf of IGNITE (Initiative of German Neurointensive Trial Engagement) and was published by The Journal of the American Medical Association (JAMA) on February 24, 2015. The study compared outcome for patients using two different mode of reversal treatments: (1) Fresh Frozen Plasma (FFP), and (2) Prothrombin Complex Concentrates (PCC).

Complexity

Data used for this clinical trial was collected from all consecutive adult patients with spontaneous ICH related to anticoagulation admitted to neurological departments between the years 2006 and 2010 with a 1-year follow-up period ending in January 2012. ICH patients with secondary etiologies, i.e., ICH related to trauma, tumor, arteriovenous malformation, aneurysmal subarachnoid hemorrhage, acute thrombolysis, or other coagulopathies, were excluded from the study. The study was titled as RETRACE (German-wide Multicenter Analysis of Oral Anticoagulation-associated Intracerebral Hemorrhage) and was conducted on behalf of IGNITE (Initiative of German Neurointensive Trial Engagement).

Data were extracted on demographics, prior comorbidities, in-hospital parameters, and laboratory data through review of patients’ medical records and institutional prospective databases. Follow-up data on mortality, functional outcome, long-term treatment, and complications by mailed questionnaires and—if not returned or incomplete—by semi-quantitative telephone interviews were obtained.

**Data synthesis and analysis:**
Reversal treatment consisted of prothrombin complex concentrates ([PCCs] 4-factor concentrate, containing coagulation factors II, VII, IX, and X as well as protein C and S), fresh-frozen plasma (FFP), antithrombin, and intravenous vitamin K—eventually in combinations. The first international normalized ration (INR) value obtained after initiation of reversal treatment is referred to as first INR monitoring after reversal. Specifically, all available laboratory results of coagulation parameters were evaluated for 72 hours after admission and the laboratory accessioning times were chosen as data points for monitoring of serial INR values. For accuracy of data on INR reversal, the initial laboratory parameters for transferred patients were retrieved from referring hospitals.

**Statistical analysis**
Prothrombin complex concentrates reversed elevated INR levels to a greater extent (absolute median INR reversal using PCCs, 1.45 [IQR, 0.97-2.10] vs Fresh frozen plasma, 0.36 [IQR, 0.04-0.86]; P < .001); however, sample size (of patients with Fresh frozen plasma only) was too small to draw firm conclusions regarding efficacy.

Date Created

2013-04-09

Last Modified

2014-02-25

Version

2014-02-25

Update Frequency

Never

Temporal Coverage

2006-2012

Spatial Coverage

Germany

Source

John Snow Labs => The Journal of the American Medical Association (JAMA)

Source License URL

John Snow Labs Standard License

Source License Requirements

N/A

Source Citation

Multicenter Analysis of Oral Anticoagulation-associated Intracerebral Hemorrhage (RETRACE), IGNITE (Initiative of German Neurointensive Trial Engagement)

Keywords

Anticoagulant Therapy, Clotting Factors, Novel Anticoagulants Data, Prothrombin Concentrate, Pulmonary Embolism Treatment, Novel Anticoagulants, Anticoagulant Study, JAMA Studies, Long-term Oral Anticoagulation Therapy, Anticoagulant Therapy Outcomes

Other Titles

Subgroup Analysis for Mode of Reversal Treatment Anticoagulant Therapy, Subgroup Analysis for Mode of Reversal Treatment Clotting Factors, Subgroup Analysis for Mode of Reversal Treatment Novel Anticoagulants, Subgroup Analysis for Mode of Reversal Treatment FFP vs Prothrombin Concentrate

NameDescriptionTypeConstraints
Coagulation_ParametersDescription of the parameters used in the selection of criteria and measurement of the outcomes of the clinical trial.string-
Point_of_ComparisonDescription of the points of comparison used in comparing the outcomes between the use of Fresh - Frozen Plasma (FFP) and Prothrombin Complex Concentrates (PCC).string-
Reversal_Treatment_Values_for_Fresh_Frozen_Plasma_MedianDescription of the median reversal treatment unique values using Fresh Frozen Plasma (FFP).stringunique : 1 required : 1
Reversal_Treatment_Values_for_Fresh_Frozen_Plasma_IQRDescription of the interquartile range (IQR) reversal treatment unique values using Fresh Frozen Plasma (FFP).stringunique : 1 required : 1
Reversal_Treatment_Values_for_Prothrombin_Complex_Concentrates_MedianDescription of the median reversal treatment unique values using Prothrombin Complex Concentrates (PCC).stringunique : 1 required : 1
Reversal_Treatment_Values_for_Prothrombin_Complex_Concentrates_IQRDescription of the interquartile range (IQR) reversal treatment unique values using Prothrombin Complex Concentrates (PCC).stringunique : 1 required : 1
ProbabilityDescription of effectiveness of the results of the clinical trial based on the hypothesis of the study.stringunique : 1 required : 1
NotesDescription of special notes or variables concerned with the hypothesis of the study.string-
Coagulation_ParametersPoint_of_ComparisonReversal_Treatment_Values_for_Fresh_Frozen_Plasma_MedianReversal_Treatment_Values_for_Fresh_Frozen_Plasma_IQRReversal_Treatment_Values_for_Prothrombin_Complex_Concentrates_MedianReversal_Treatment_Values_for_Prothrombin_Complex_Concentrates_IQRProbabilityNotes
Hematoma enlargement545.423636.30.75
Partial thromboplastin time (PTT)34(32-38)33(30-37)0.35
Absolute INR reversal0.36(0.04-0.86)1.45(0.97-2.10)<.001
Partial thromboplastin time, Median (PTT)40(34-49)42(36-49)0.66
Initial coagulation parametersInternational normalized ratio (INR)2.2(1.84-3.45)2.47(2.30-3.45)0.11
First monitoring after reversalInternational normalized ratio (INR)1.66(1.20-2.42)1.27(1.15-1.44)0.01Not significant after Bonferroni correction (corrected significance level P <.00104
First monitoring after reversalInternational normalized ratio (INR)1.66(1.20-2.42)1.27(1.15-1.44)0.01Not significant after Bonferroni correction (corrected significance level P <.00104
First monitoring after reversalInternational normalized ratio (INR)1.66(1.20-2.42)1.27(1.15-1.44)0.01Not significant after Bonferroni correction (corrected significance level P <.00104
First monitoring after reversalInternational normalized ratio (INR)1.66(1.20-2.42)1.27(1.15-1.44)0.01Not significant after Bonferroni correction (corrected significance level P <.00104
First monitoring after reversalInternational normalized ratio (INR)1.66(1.20-2.42)1.27(1.15-1.44)0.01Not significant after Bonferroni correction (corrected significance level P <.00104