Пилотное исследование и регистрация антикоагулянтной терапии после желудочно-кишечного кровотечения (PANTHER-GI)

For patients at high thrombotic risk, DOACs will be resumed within 7 days of clinical hemostasis after GI bleeding.

In patients at high thrombotic risk, DOACs will be resumed within 7 days of clinical hemostasis (as judged by the clinical team).

High thrombotic risk includes the following:

(i) Atrial fibrillation or atrial flutter with CHA2DS2VASc score of 5 or higher (ii) Atrial fibrillation or atrial flutter with CHA2DS2VASc score or 3 to 4 with recent ischemic stroke, TIA or systemic embolism (within 6 months) (iii) VTE (proximal DVT or PE) within 3 months (iv) Recurrent VTE (proximal DVT or PE) (v) VTE (proximal DVT or PE) associated with antiphospholipid syndrome (if eligible for DOAC) (vi) VTE (proximal DVT or PE) associated with active non-GI cancer (vii) None of the above but considered high thrombotic risk as per investigator

For patients at moderate thrombotic risk, DOACs will be resumed between 7 and 14 days of clinical hemostasis after GI bleeding.

In patients at moderate thrombotic risk, DOACs will be resumed between 7 and 14 days of clinical hemostasis (as judged by the clinical team).

Moderate thrombotic risk includes the following:

(i) Atrial fibrillation or atrial flutter with CHA2DS2VASc score of 3 to 4 (ii) VTE (proximal DVT or PE) beyond 3 months

The type and dose of DOAC will be according to patient and physician choice and will be prescribed by the clinical care team.

The pilot study will be considered a success and to have demonstrated feasibility if average recruitment of 2 patients per month at each site is achieved.

Feasibility criterion of achieving recruitment of 85% of the target sample size of 100 patients

proportion of patients screened who are eligible to participate out of all patients screened

proportion of eligible patients who provide consent to participate out of all eligible patients

proportion of patients who complete all required study procedures out of all enrolled patients

proportion of patients who adhere to study treatment strategy (i.e. resumed DOAC within the specified timeframe) out of the total number of patients enrolled

proportion of patients with repeat endoscopy for suspected bleeding after index GI bleed out of all enrolled patients

number of patients re-hospitalization for GI bleeding after index GI bleed out of all patients enrolled

number of patients with major bleeding (as per International Society on Thrombosis and Haemostasis [ISTH] criteria) out of all patients enrolled

number of patients with clinically relevant non-major bleeding (CRNMB; as per ISTH) out of all patients enrolled

number of patients who experience composite of acute ischemic stroke, transient ischemic attack or systemic embolism our of all patients enrolled

number of patients with acute objectively confirmed venous thromboembolism (symptomatic proximal lower extremity deep vein thrombosis [DVT], symptomatic pulmonary embolism [PE] as per ISTH) out of all patients enrolled

number of patients experiencing composite of stroke, systemic embolic event, major bleeding, or death from any cause out of all patients enrolled

number of patients who die of all causes out of all patients enrolled

Change in functional status measured using Standard Assessment of Global Activities in the Elderly (SAGE) scale at 90 days compared to baseline.

SAGE is a 15-item scale that represents a measure of activities of daily living (ADL) across the spectrum of functioning (cognitive, instrumental and basic ADL). The SAGE is supplemented with additional measures of cognition, mood, and quality of life.

The minimum SAGE score - which corresponds to no functional impairments - is 0. The maximum SAGE score - which corresponds to severe global functional impairment - is 45.

Quality of life measured using EuroQol-5D [EQ-5D®] at 90 days compared to baseline.

The EQ-5D instrument comprises a descriptive system questionnaire and a visual analogue scale (EQ VAS). The questionnaire provides a descriptive profile of a respondent's health state representing the level of reported problems on each of the five dimensions of health (mobility, self-care, usual activities, pain or discomfort, anxiety/depression) that can be converted into a single index value. Average index values (expressed as mean and standard deviation or median and interquartile range depending on skewness) at 90 days will be compared to baseline.

The EQ VAS elicits an individual's rating of their own overall current health (0-100 scale where 0 is the worst health you can imagine and 100 is best health you can imagine). Average EQ VAS ratings (expressed as mean and standard deviation or median and interquartile range depending on skewness) at 90 days will be compared to baseline.