Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2019; 119(12): 1927-1932
DOI: 10.1055/s-0039-1696685

Coagulation and Fibrinolysis

Georg Thieme Verlag KG Stuttgart · New York

Single Low Dose of rFVIIa Combined with Antifibrinolytic Agent is a Simple and Safe Treatment for Factor XI-Deficient Patients undergoing Surgery

Ophira Salomon

¹Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

²Institute of Thrombosis and Hemostasis, Sheba Medical Center, Tel-Hashomer, Israel

,

Ivan Budnik

³Department of Pathophysiology, Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia

,

Einat Avishai

¹Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

⁴National Hemophilia Center and Thrombosis Unit, Sheba Medical Center, Tel-Hashomer, Israel

⁵The Amalia Biron Thrombosis Research Institute, Sheba Medical Center, Tel-Hashomer, Israel

,

Ilia Tamarin

⁴National Hemophilia Center and Thrombosis Unit, Sheba Medical Center, Tel-Hashomer, Israel

⁵The Amalia Biron Thrombosis Research Institute, Sheba Medical Center, Tel-Hashomer, Israel

,

Dalia Bashari

⁴National Hemophilia Center and Thrombosis Unit, Sheba Medical Center, Tel-Hashomer, Israel

⁵The Amalia Biron Thrombosis Research Institute, Sheba Medical Center, Tel-Hashomer, Israel

,

Rima Dardik

⁴National Hemophilia Center and Thrombosis Unit, Sheba Medical Center, Tel-Hashomer, Israel

⁵The Amalia Biron Thrombosis Research Institute, Sheba Medical Center, Tel-Hashomer, Israel

,

Tami Livnat

¹Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

⁴National Hemophilia Center and Thrombosis Unit, Sheba Medical Center, Tel-Hashomer, Israel

⁵The Amalia Biron Thrombosis Research Institute, Sheba Medical Center, Tel-Hashomer, Israel

› Author Affiliations

Abstract

Background Factor XI (FXI) deficiency is a rare autosomal bleeding disorder. The rarity of spontaneous bleeding and absence of optimal tools to predict the bleeding risk in FXI-deficient patients hamper the standardization of prophylactic treatment enabling them to undergo major surgeries without blood products.

Objectives We explored the effectiveness of a single and very low dose of recombinant factor VIIa (rFVIIa) along with tranexamic acid (TXA) as prophylactic treatment for FXI-deficient patients undergoing various types of surgery at various sites of injury. We studied the potential use of thrombin generation (TG) as a surrogate tool for predicting thrombogenicity.

Patients and Methods Our cohort consisted of 10 patients with severe FXI deficiency undergoing 12 interventions. Patients received a single dose of 10 to 15 μg/kg rFVIIa at the end of surgery in addition to TXA initiated 2 hours before surgery at the dose of 4 g/day for 3 to 5 days. TG was tested before and 30 minutes after rFVIIa administration.

Results All operations were uneventful and none of the patients bled excessively or required blood products. No thrombotic event was reported, and the postoperative hospitalization duration was comparable to that of patients without bleeding disorders. TG performed at the peak of rFVIIa was below the curve of healthy controls, thus confirming that the administered dose was not thrombogenic.

Conclusion A single very low dose of rFVIIa along with TXA is a simple and safe treatment to control hemostasis in severe FXI-deficient patients undergoing diverse type of surgical procedure at various sites.

Keywords

Keywords

factor XI - rFVIIa - thrombin generation - surgery - hemostasis

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