PMID- 18327412
OWN - NLM
STAT- MEDLINE
DCOM- 20080515
LR  - 20080310
IS  - 0340-6245 (Print)
IS  - 0340-6245 (Linking)
VI  - 99
IP  - 3
DP  - 2008 Mar
TI  - Antithrombin alfa in hereditary antithrombin deficient patients: A phase 3 study 
      of prophylactic intravenous administration in high risk situations.
PG  - 616-22
LID - 10.1160/TH07-08-0489 [doi]
AB  - During surgery and childbirth, patients with hereditary antithrombin (AT) 
      deficiency are at high risk for thrombosis, and heparin prophylaxis may not be 
      sufficiently efficacious. In these patients, exogenous AT may be used in 
      association with heparin. A recombinant human AT (generic name: antithrombin 
      alfa) has been developed. This multi-center study assessed the efficacy and 
      safety of prophylactic intravenous administration of antithrombin alfa to 
      hereditary AT deficient patients in high risk situations, including elective 
      surgery, childbirth, or cesarean section. Antithrombin alfa was administered 
      prior to and during the high risk period for restoration and maintenance of AT 
      activity at 100% of normal. Heparin, low-molecular-weight heparin, and/or vitamin 
      K antagonists were used according to standard of care. The primary efficacy 
      endpoint was the incidence of acute deep vein thrombosis (DVT) from baseline up 
      to day 30 post dosing as assessed by independent central review of duplex 
      ultrasonograms and/or venograms. Safety was assessed based on adverse events 
      (AEs) and laboratory evaluations. Five surgical and nine obstetrical hereditary 
      AT deficiency patients received antithrombin alfa for a mean period of seven 
      days. No clinically overt DVT occurred. Central review of ultrasonograms 
      identified signs of acute DVT in two out of 13 evaluable patients. No 
      antithrombin alfa-related AEs were reported. No patient developed 
      anti-antithrombin alfa antibodies. In conclusion, this study suggests that 
      antithrombin alfa is a safe and effective alternative to human plasma-derived AT 
      for treating hereditary AT deficiency patients at high risk for thromboembolic 
      events.
FAU - Tiede, Andreas
AU  - Tiede A
AD  - Hannover Medical School, Dept. of Haematology, Haemostasis, Oncology & Stem Cell 
      Transplantation, Germany. tiede.andreas@mh-hannover.de
FAU - Tait, R Campbell
AU  - Tait RC
FAU - Shaffer, Don W
AU  - Shaffer DW
FAU - Baudo, Francesco
AU  - Baudo F
FAU - Boneu, Bernard
AU  - Boneu B
FAU - Dempfle, Carl Erik
AU  - Dempfle CE
FAU - Horellou, Marie Helene
AU  - Horellou MH
FAU - Klamroth, Robert
AU  - Klamroth R
FAU - Lazarchick, John
AU  - Lazarchick J
FAU - Mumford, Andrew D
AU  - Mumford AD
FAU - Schulman, Sam
AU  - Schulman S
FAU - Shiach, Caroline
AU  - Shiach C
FAU - Bonfiglio, Laura J
AU  - Bonfiglio LJ
FAU - Frieling, Johan T M
AU  - Frieling JT
FAU - Conard, Jacqueline
AU  - Conard J
FAU - von Depka, Mario
AU  - von Depka M
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - Germany
TA  - Thromb Haemost
JT  - Thrombosis and haemostasis
JID - 7608063
RN  - 0 (Anticoagulants)
RN  - 0 (Antithrombins)
RN  - 0 (Recombinant Proteins)
RN  - 9005-49-6 (Heparin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Anticoagulants/*administration & dosage/adverse effects
MH  - Antithrombins/*administration & dosage/adverse effects/deficiency/genetics
MH  - Arthroplasty, Replacement, Hip/adverse effects
MH  - Blood Coagulation/drug effects
MH  - Blood Coagulation Disorders, Inherited/blood/complications/*drug therapy/genetics
MH  - Cesarean Section/adverse effects
MH  - Delivery, Obstetric/adverse effects
MH  - Drug Administration Schedule
MH  - Europe
MH  - Female
MH  - Heparin/therapeutic use
MH  - Humans
MH  - Infusions, Intravenous
MH  - Male
MH  - Mammaplasty/adverse effects
MH  - Middle Aged
MH  - Phlebography
MH  - Prospective Studies
MH  - Recombinant Proteins/administration & dosage
MH  - Time Factors
MH  - Treatment Outcome
MH  - Ultrasonography, Doppler, Duplex
MH  - United States
MH  - Venous Thrombosis/blood/etiology/genetics/pathology/*prevention & control
EDAT- 2008/03/11 09:00
MHDA- 2008/05/16 09:00
CRDT- 2008/03/11 09:00
PHST- 2008/03/11 09:00 [pubmed]
PHST- 2008/05/16 09:00 [medline]
PHST- 2008/03/11 09:00 [entrez]
AID - 08030616 [pii]
AID - 10.1160/TH07-08-0489 [doi]
PST - ppublish
SO  - Thromb Haemost. 2008 Mar;99(3):616-22. doi: 10.1160/TH07-08-0489.