PMID- 8901773
OWN - NLM
STAT- MEDLINE
DCOM- 19961206
LR  - 20071115
IS  - 0009-7322 (Print)
IS  - 0009-7322 (Linking)
VI  - 94
IP  - 9 Suppl
DP  - 1996 Nov 1
TI  - Randomized trial of recombinant platelet factor 4 versus protamine for the 
      reversal of heparin anticoagulation in humans.
PG  - II347-52
AB  - BACKGROUND: Protamine reverses heparin anticoagulation, but it can have important 
      side effects. We compared the safety and effectiveness of intravenous recombinant 
      platelet factor 4 (rPF4) as an alternative to protamine in a randomized blinded 
      trial. METHODS AND RESULTS: In 81 patients having diagnostic cardiac 
      catheterization, baseline hemodynamics were measured after a 5000-U bolus of 
      heparin. Repeat measurements were obtained at the end of the procedure, and the 
      anticoagulation status was determined by an activated coagulation time (ACT) and 
      activated partial thromboplastin time (aPTT). Patients then received either 
      protamine (50 mg IV over 10 minutes) or rPF4 (1.0 mg/kg IV over 2 minutes) in a 
      blinded fashion. Serial measurements of hemodynamic and clotting functions were 
      performed 5, 10, 20, and 30 minutes after drug administration. Follow-up 
      measurements and clinical assessments were made at 1, 4, 6, and 24 hours later 
      and after 7 days. Before drug administration, ACTs, aPTTs, and hemodynamics were 
      similar among the groups. After drug infusion, there was no difference in ACT 
      between the protamine and rPF4 patients. At 20 and 30 minutes after drug 
      infusion, ACT and aPTT were slightly higher in those receiving rPF4, but these 
      changes were small and of no clinical significance. There were no clinically 
      meaningful differences in any of the hemodynamic variables between the groups, 
      and there were no serious side effects in any patient. CONCLUSIONS: At the dose 
      used in this study, rPF4 was well tolerated and reversed the anticoagulant effect 
      of heparin. These data support its continued evaluation as an alternative to 
      protamine after cardiac surgery.
FAU - Dehmer, G J
AU  - Dehmer GJ
AD  - Cardiac Catheterization Laboratories, University of North Carolina Hospitals, 
      Chapel Hill 27514, USA.
FAU - Lange, R A
AU  - Lange RA
FAU - Tate, D A
AU  - Tate DA
FAU - Pirwitz, M
AU  - Pirwitz M
FAU - Daniel, W
AU  - Daniel W
FAU - Fisher, M
AU  - Fisher M
FAU - Bonnem, E M
AU  - Bonnem EM
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Circulation
JT  - Circulation
JID - 0147763
RN  - 0 (Heparin Antagonists)
RN  - 0 (Protamines)
RN  - 0 (Recombinant Proteins)
RN  - 37270-94-3 (Platelet Factor 4)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Female
MH  - Hemodynamics/drug effects
MH  - Heparin Antagonists/*pharmacology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Platelet Factor 4/adverse effects/*pharmacology
MH  - Protamines/*pharmacology
MH  - Recombinant Proteins/pharmacology
EDAT- 1996/11/01 00:00
MHDA- 1996/11/01 00:01
CRDT- 1996/11/01 00:00
PHST- 1996/11/01 00:00 [pubmed]
PHST- 1996/11/01 00:01 [medline]
PHST- 1996/11/01 00:00 [entrez]
PST - ppublish
SO  - Circulation. 1996 Nov 1;94(9 Suppl):II347-52.