Abstract
Introduction: Ensuring hemostasis during invasive procedures is a challenge in patients with severe hemophilia A. This analysis evaluated efficacy and safety of BAY 94-9027, an extended-half-life recombinant factor VIII (FVIII), in the surgical setting. Materials and methods: Patients participating in an open-label BAY 94-9027 clinical trial who underwent major surgery were included in the analysis. Investigator/surgeon assessment of hemostasis during surgery was the primary outcome. In addition, information about FVIII use, FVIII levels during perioperative period, bleeding complications and FVIII inhibitor development were collected. Results: Data were analyzed for 26 major surgeries (orthopedic, n = 21) in 20 patients aged 13–61 years. BAY 94-9027 provided effective hemostasis during all procedures. FVIII levels 6–8 h post preoperative infusion and prior to the first follow-up infusion were in the range expected to maintain protection in the major surgery setting. The median time from preoperative infusion to the first follow-up infusion (the first infusion administered after the preoperative infusion) was 12.33 (3.6–49.9) h. No intraoperative bleeding complications occurred, and no new inhibitors developed following any surgery. Conclusions: The results of the study demonstrate that BAY 94-9027 was efficacious and well tolerated in the treatment of patients undergoing major surgeries. Advantages of BAY 94-9027 include the potential for less frequent infusion and reduced factor consumption, which should simplify the management of patients during major surgery.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 13-19 |
| Number of pages | 7 |
| Journal | Thrombosis research |
| Volume | 183 |
| DOIs | |
| State | Published - Nov 1 2019 |
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Keywords
- Extended-half-life factor VIII
- Hemophilia A
- Recombinant protein
- Surgery
ASJC Scopus subject areas
- Hematology
Cite this
Safety and efficacy of BAY 94-9027, an extended-half-life factor VIII, during surgery in patients with severe hemophilia A : Results of the PROTECT VIII clinical trial. / Santagostino, Elena; Lalezari, Shadan; Reding, Mark T.; Ducore, Jonathan M; Ng, Heng Joo; Poulsen, Lone H.; Michaels, Lisa A.; Linardi, Camila C.G.
In: Thrombosis research, Vol. 183, 01.11.2019, p. 13-19.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Safety and efficacy of BAY 94-9027, an extended-half-life factor VIII, during surgery in patients with severe hemophilia A
T2 - Results of the PROTECT VIII clinical trial
AU - Santagostino, Elena
AU - Lalezari, Shadan
AU - Reding, Mark T.
AU - Ducore, Jonathan M
AU - Ng, Heng Joo
AU - Poulsen, Lone H.
AU - Michaels, Lisa A.
AU - Linardi, Camila C.G.
PY - 2019/11/1
Y1 - 2019/11/1
N2 - Introduction: Ensuring hemostasis during invasive procedures is a challenge in patients with severe hemophilia A. This analysis evaluated efficacy and safety of BAY 94-9027, an extended-half-life recombinant factor VIII (FVIII), in the surgical setting. Materials and methods: Patients participating in an open-label BAY 94-9027 clinical trial who underwent major surgery were included in the analysis. Investigator/surgeon assessment of hemostasis during surgery was the primary outcome. In addition, information about FVIII use, FVIII levels during perioperative period, bleeding complications and FVIII inhibitor development were collected. Results: Data were analyzed for 26 major surgeries (orthopedic, n = 21) in 20 patients aged 13–61 years. BAY 94-9027 provided effective hemostasis during all procedures. FVIII levels 6–8 h post preoperative infusion and prior to the first follow-up infusion were in the range expected to maintain protection in the major surgery setting. The median time from preoperative infusion to the first follow-up infusion (the first infusion administered after the preoperative infusion) was 12.33 (3.6–49.9) h. No intraoperative bleeding complications occurred, and no new inhibitors developed following any surgery. Conclusions: The results of the study demonstrate that BAY 94-9027 was efficacious and well tolerated in the treatment of patients undergoing major surgeries. Advantages of BAY 94-9027 include the potential for less frequent infusion and reduced factor consumption, which should simplify the management of patients during major surgery.
AB - Introduction: Ensuring hemostasis during invasive procedures is a challenge in patients with severe hemophilia A. This analysis evaluated efficacy and safety of BAY 94-9027, an extended-half-life recombinant factor VIII (FVIII), in the surgical setting. Materials and methods: Patients participating in an open-label BAY 94-9027 clinical trial who underwent major surgery were included in the analysis. Investigator/surgeon assessment of hemostasis during surgery was the primary outcome. In addition, information about FVIII use, FVIII levels during perioperative period, bleeding complications and FVIII inhibitor development were collected. Results: Data were analyzed for 26 major surgeries (orthopedic, n = 21) in 20 patients aged 13–61 years. BAY 94-9027 provided effective hemostasis during all procedures. FVIII levels 6–8 h post preoperative infusion and prior to the first follow-up infusion were in the range expected to maintain protection in the major surgery setting. The median time from preoperative infusion to the first follow-up infusion (the first infusion administered after the preoperative infusion) was 12.33 (3.6–49.9) h. No intraoperative bleeding complications occurred, and no new inhibitors developed following any surgery. Conclusions: The results of the study demonstrate that BAY 94-9027 was efficacious and well tolerated in the treatment of patients undergoing major surgeries. Advantages of BAY 94-9027 include the potential for less frequent infusion and reduced factor consumption, which should simplify the management of patients during major surgery.
KW - Extended-half-life factor VIII
KW - Hemophilia A
KW - Recombinant protein
KW - Surgery
UR - http://www.scopus.com/inward/record.url?scp=85071912151&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85071912151&partnerID=8YFLogxK
U2 - 10.1016/j.thromres.2019.08.023
DO - 10.1016/j.thromres.2019.08.023
M3 - Article
VL - 183
SP - 13
EP - 19
JO - Thrombosis Research
JF - Thrombosis Research
SN - 0049-3848
ER -