Document Detail


Safety and preliminary efficacy of hemoglobin raffimer for patients undergoing coronary artery bypass surgery.
MedLine Citation:
PMID:  12486649     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To evaluate the safety and preliminary efficacy of escalating doses of hemoglobin raffimer (Hemolink) with intraoperative autologous blood donation for coronary artery bypass graft (CABG) surgery. DESIGN: Randomized, controlled, single-blind phase II dose escalation trial. SETTING: Multi-institutional university setting. PARTICIPANTS: Adult patients (n = 60) undergoing elective CABG surgery. INTERVENTIONS: After induction of anesthesia, autologous whole blood was collected to achieve a hemoglobin of 7 g/dL on cardiopulmonary bypass. Patients were randomized to receive either hemoglobin raffimer (treatment) or 6% hetastarch (control) in sequential escalating dose blocks of 250 mL, 500 mL, or 750 mL. After return of autologous blood, allogeneic red blood cells were transfused according to predetermined hemoglobin triggers. MEASUREMENTS AND MAIN RESULTS: Safety parameters (vital signs, hematology, blood chemistry, coagulation, and adverse events) were monitored from randomization through week 4 postdischarge. Serious adverse events were distributed evenly between the 2 groups of patients. Elevated blood pressure was more frequent in the treatment group (16/28 mmHg v 9/32 mmHg, p = 0.036). In the group of 40 patients in the 750-mL dose block, 8 of the 18 treatment patients and 4 of the 22 control patients avoided allogeneic red blood cell transfusion (p = 0.093). Median volume of allogeneic red blood cells transfused was lower in treated subjects compared with controls (p = 0.042). CONCLUSION: Hemoglobin raffimer is well tolerated and may be effective in reducing transfusion for patients undergoing CABG surgery. Although perioperative hypertension was more frequent in the treated patients, blood pressure management prevented serious adverse sequelae. Definitive evaluation of efficacy in a larger phase III trial is warranted.
Authors:
Steven E Hill; Lewis I Gottschalk; Katherine Grichnik
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Publication Detail:
Type:  Clinical Trial; Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of cardiothoracic and vascular anesthesia     Volume:  16     ISSN:  1053-0770     ISO Abbreviation:  J. Cardiothorac. Vasc. Anesth.     Publication Date:  2002 Dec 
Date Detail:
Created Date:  2002-12-17     Completed Date:  2003-04-02     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9110208     Medline TA:  J Cardiothorac Vasc Anesth     Country:  United States    
Other Details:
Languages:  eng     Pagination:  695-702     Citation Subset:  IM    
Copyright Information:
Copyright 2002, Elsevier Science (USA). All rights reserved.
Affiliation:
Department of Anesthesiology and Critical Care, Duke University Medical Center, Durham, NC 27710, USA. hill0012@mc.duke.edu
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MeSH Terms
Descriptor/Qualifier:
Blood Transfusion, Autologous*
Coronary Artery Bypass*
Female
Hemoglobins / administration & dosage*,  adverse effects
Hetastarch / administration & dosage
Humans
Male
Middle Aged
Plasma Substitutes / administration & dosage
Raffinose / administration & dosage*,  adverse effects,  analogs & derivatives*
Single-Blind Method
Chemical
Reg. No./Substance:
0/Hemoglobins; 0/O-raffinose cross-linked human hemoglobin; 0/Plasma Substitutes; 512-69-6/Raffinose; 9005-27-0/Hetastarch

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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