Tuesday, July 1, 2025 7/1/2025

Prediction of Anticoagulant-Related Bleeding Risk in Patients with Cancer

Award Number: R01HL166386
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/05/2023
PERIOD OF PERFORMANCE END DATE: 11/30/2026

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Prediction of Anticoagulant-Related Bleeding Risk in Patients with Cancer - Project Summary Among patients with cancer, the risk of anticoagulant-related major bleeding is more than double that of patients without cancer. These bleeds have a fatality rate of 7%. Current guidelines recommend indefinite anticoagulant therapy in many patients with cancer and venous thromboembolism (VTE) with periodic assessments of bleeding risk. However, no evidence-based models exist to quantify bleeding risk in patients with cancer taking anticoagulants. In addition, recent trials have demonstrated effectiveness of direct oral anticoagulants as primary prophylaxis for prevention of initial VTE in patients with cancer. Thus, there is a strong need to balance the competing risks of VTE and anticoagulant-related bleeding in patients with cancer. While there are models that quantify bleeding risk in non-cancer populations (i.e. atrial fibrillation, non- cancer associated VTE) taking anticoagulants, they have not been validated in patients with cancer. Quantification of bleeding risk in patients with cancer and VTE would allow for an evidence-based approach to preventing and treating VTE by minimizing anticoagulant therapy in patients at high-risk of bleeding and allowing for judicial use in patients at low-risk of bleeding. The overall objective of this study is to develop a prediction model for anticoagulant-related bleeding in patients with cancer and VTE on anticoagulant therapy and to calibrate that model in cancer patients at high-risk of VTE being considered for primary thromboprophylaxis with anticoagulant therapy. We will accomplish our overall objective through the following specific aims: (1) validate eight existing bleeding prediction models in a cohort of 7489 patients with cancer and VTE receiving anticoagulant therapy, (2) refine and validate a cancer-specific prediction model to quantify risk of anticoagulant-associated bleeding in patients with cancer on anticoagulant therapy for VTE, and (3) calibrate the refined bleeding prediction model in a cohort of patients with cancer receiving primary anticoagulant thromboprophylaxis enrolled in two randomized trials (AVERT and CASSINI). These aims will be addressed with an expert research team in the areas of bleeding, VTE (especially in patients with cancer) and development and implementation of risk prediction models. This proposal is innovative as it addresses a current gap in the management of patients with cancer with or at high-risk of VTE by developing a prediction model to quantify the risk of the intervention (anticoagulant therapy) to inform and guide patient care. This research will be significant because it has the potential to decrease anticoagulant-related bleeding and thus bleeding related morbidity and mortality in patients with cancer.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $389,391 )
2025	2025	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Blood Diseases and Resources Research	001	3	4/9/2025	NON-COMPETING CONTINUATION	$0
2025	2025	WASHINGTON UNIVERSITY, THE	1 BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Blood Diseases and Resources Research	000	3	11/25/2024	NON-COMPETING CONTINUATION	$389,391
														Subtotal = $389,391

Issue Date FY: 2024 ( Subtotal = $392,869 )
2024	2024	WASHINGTON UNIVERSITY, THE	ONE BROOKINGS DR	SAINT LOUIS	MO	63110	SAINT LOUIS CITY	USA	Blood Diseases and Resources Research	000	2	11/8/2023	NON-COMPETING CONTINUATION	$392,869
														Subtotal = $392,869

Issue Date FY: 2023 ( Subtotal = $402,359 )
2023	2023	WASHINGTON UNIVERSITY, THE	ONE BROOKINGS DR	SAINT LOUIS	MO	63130	SAINT LOUIS	USA	Blood Diseases and Resources Research	000	1	1/5/2023	NEW	$402,359
														Subtotal = $402,359

Grand Total All Awards = $1,184,619

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Prediction of Anticoagulant-Related Bleeding Risk in Patients with Cancer

Award Number: R01HL166386

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 01/05/2023

PERIOD OF PERFORMANCE END DATE: 11/30/2026

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