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Measurement of Factor V Activity in Human Plasma Using a Microplate Coagulation Assay
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CT-001, a novel fast-clearing factor VIIa, enhanced the hemostatic activity in postpartum samples
Derek S Sim1, Cornell R Mallari1, Terry W Hermiston1
1Coagulant Therapeutics, Berkeley, CA.
Blood Advances
|December 1, 2023
Summary
The hemostatic system remains active after childbirth, with maintained thrombin generation despite factor consumption. Both recombinant factor VIIa (rFVIIa) and CT-001 enhance clotting, with CT-001 showing superior efficacy in postpartum hemorrhage (PPH) treatment.
Area of Science:
- Hematology
- Obstetrics
- Pharmacology
Background:
- The hemostatic system is crucial for preventing hemorrhage during childbirth.
- Limited data exists on hemostatic changes immediately before and after delivery.
- Recombinant factor VIIa (rFVIIa) is approved for postpartum hemorrhage (PPH), with CT-001 as a next-generation therapy.
Purpose of the Study:
- To evaluate the peripartum hemostatic status in pregnant women.
- To assess the ex vivo hemostatic activity of rFVIIa and CT-001 in peripartum blood.
Main Methods:
- Prospective observational study of pregnant women at two sites.
- Blood samples collected up to 3 days before delivery and 45 (±15) minutes after delivery.
- Analysis of coagulation markers, thrombin generation, and viscoelastic hemostasis assays with and without rFVIIa and CT-001.
Main Results:
- Postdelivery showed increased soluble fibrin monomer and D-dimer, with decreased tissue factor, FVIII, FV, and fibrinogen.
- Thrombin generation assay revealed shortened lag time and time to peak, with maintained peak thrombin capacity post-delivery.
- Both rFVIIa and CT-001 enhanced clotting activity in postdelivery samples; CT-001 demonstrated greater efficacy.
Conclusions:
- Despite coagulation factor consumption, thrombin generation is maintained around delivery.
- rFVIIa and CT-001 effectively enhance hemostatic activity in postpartum blood samples.
- CT-001 exhibits greater procoagulant activity compared to rFVIIa, suggesting potential for improved PPH management.
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