Abstract: A highly sensitive blood coagulation test reagent that enables determining and evaluating bleeding risk of direct oral anticoagulants (DOACs) and the like accurately in hemorrhagic diseases, and the like are provided. A blood coagulation test reagent containing: an active form of a blood coagulation factor XI (FXIa); and tissue factor (TF). A blood coagulation test method including a step of measuring the amount of thrombin generated by reacting a biological sample as a test specimen with a test reagent containing: 0.5 pM to 1,000 pM of an active form of a blood coagulation factor XI(FXIa); and 1 fM to 1,000 fM of tissue factor.

Abstract: In various embodiments, disclosed herein are methods of assessing therapeutic efficacy of an anticoagulant. Preferably, the method comprising providing a blood sample; perfusing the blood sample over a surface coated with collagen or immobilized rTF; measuring platelet aggregation and fibrin deposition on the surface coated with collagen or immobilized rTF; and assessing therapeutic efficacy of the anticoagulant based on the volume of platelet aggregates and/or deposited fibrin.

Abstract: In various embodiments, disclosed herein are assays for measuring thrombin generated (TG) in a blood sample, comprising: incubating the blood sample with TF, FIXa, and CaCl2; and measuring TG in the blood sample. Also disclosed herein are assays for determining a bleeding risk in a subject, comprising obtaining a blood sample from the subject; adding to the blood sample TF and/or FIXa; determining the amount of coagulation factor VIII (FVIII:C) in the blood sample; and determining (a) a mild bleeding risk in the subject if the amount of FVIII:C in the sample is >5 IU/dL, (b) a moderate bleeding risk in the subject if the amount of FVIII:C in the sample is 1-5 IU/dL, and (c) a severe bleeding risk in the subject if the amount of FVIII:C in the subject is <1 IU/dL.

Abstract: In various embodiments, disclosed herein are assays for measuring thrombin generated (TG) in a blood sample, comprising: incubating the blood sample with TF, FIXa, and CaCl2; and measuring TG in the blood sample. Also disclosed herein are assays for determining a bleeding risk in a subject, comprising obtaining a blood sample from the subject; adding to the blood sample TF and/or FIXa; determining the amount of coagulation factor VIII (FVIII:C) in the blood sample; and determining (a) a mild bleeding risk in the subject if the amount of FVIII:C in the sample is >5 IU/dL, (b) a moderate bleeding risk in the subject if the amount of FVIII:C in the sample is 1-5 IU/dL, and (c) a severe bleeding risk in the subject if the amount of FVIII:C in the subject is <1 IU/dL.

Abstract: In a process for preparing Tissue Factor Pathway Inhibitor (TFPI) by the genetically engineered technique by the use of a transformed animal cell wherein a DNA encoding human TFPI is introduced, the improvement which comprises culturing said transformed animal cell in a culture medium supplemented with a sulfated polysaccharide to protect an intact TFPI produced by said transformed animal cell from cleavage by proteases present in the culture medium.

Abstract: A peptide comprising a peptide (A) of an amino acid sequence being abundant in basic amino acid residues and a peptide (B) of an amino acid sequence comprising at least two consecutive, hydrophobic amino acid residues wherein the peptide (B) is linked to the C-terminal of the peptide (A) directly or via several amino acid residues. The novel peptide of the present invention has the activity to inhibit growth of smooth muscle cells and a pharmaceutical composition comprising the peptide is useful for preventing or treating pathological conditions associated with growth of smooth muscle cells such as arteriosclerosis, restenosis after angioplasty, luminal stenosis after grafting blood vessel and smooth muscle sarcoma.