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At least 37 records · Page 2Linked to original sources
PubMed1982

Haemodilution for major vascular surgery--using 3.5% polygeline (Haemaccel).

Intra-operative haemodilution and autotransfusion was carried out in 32 patients having major vascular surgery. The intra-operative blood loss and peri-operative blood replacement was compared with that in 25 patients having similar surgery in whom haemodilution was considered to be contraindicated. Both groups of patients had similar mean intra-operative blood loss measured but homologous blood transfusion requirements were significantly different; 2.6 units (SD 1.9) in the haemodiluted patients compared with 6.0 units (SD 3.5) in the non-diluted patients. There was no mortality in the haemodiluted patients nor was any morbidity attributed to the procedure. Polygeline (haemaccel) was used as the diluent and proved satisfactory for this purpose.

Aged↗
PubMed1989

[The effect of subtherapeutic quantities of native gelatin and Haemaccel 35 (polygeline) on the fibronectin level and wound healing. An experimental animal study in rats with burn wounds].

Posttraumatically, opsonic plasma fibronectin is consumed by collagen-like degradation products that enter the vascular system. Additional administration of gelatin (= denatured collagen) results in an essential lack of fibronectin with subsequent retardation of wound healing even when subtherapeutic amounts are given. Therefore, in an experiment with rats we studied the question of whether similar effects are evoked by equal amounts of Haemaccel 35 (cross-linked polypeptides from degraded gelatin). The animals received standardized third degree burn injuries of about 1% of body surface. Immediately after wounding and on the following 2 days native gelatin or Haemaccel was applied intraperitoneally in 2 different dosages (61 mg/kg and 122 mg/kg). The burn injury by itself did not cause a significant decrease of plasma fibronectin. After injection of gelatin a dramatic deprivation of plasma fibronectin occurred and, in consequence, a delay of the healing process. After administration of equal amounts of Haemaccel 35, however, there was neither a depletion of plasma fibronectin nor any significant effect on wound healing.

Animals↗
PubMed1995

A cluster of fever and hypotension on a surgical intensive care unit related to the contamination of plasma expanders by cell wall products of Bacillus stearothermophilus.

OBJECTIVE: To evaluate an outbreak of fever and hypotension after cardiac surgical procedures and the role of polygeline, a plasma expander. DESIGN: Unmatched case-control study. SETTING: A six-bed cardiac surgery intensive care unit (SICU) of the Hospital Clinic of Barcelona (Spain), a 940-bed public teaching hospital. PATIENTS: Eight cases and 25 control patients admitted to the SICU over a 4-week epidemic period. MAIN OUTCOME MEASURES: Development of hypotension (systolic blood pressure < or = 90 mm Hg or a drop of 40 mm Hg from baseline systolic blood pressure) and fever (axillary temperature > 38.5 degrees C) within 24 hours of a cardiac surgical procedure. RESULTS: The single risk factor significantly different between cases and controls was the total volume of polygeline used throughout the surgical procedure for extracorporeal circulation: a median of 1,250 mL (mean, 1,312.5 +/- 842.5 mL) in cases versus 500 mL (mean, 566.0 +/- 159.9 mL) in controls (P = .0029). By multiple logistic regression analysis, polygeline use was the single risk factor significantly related to the outcome (odds ratio, 8.75; CI95, 1.36 to 56.2; P = .01). Neither blood cultures from patients nor cultures of the polygeline used yielded growth of any microorganism. Stopping use of the implicated polygeline lot controlled the outbreak. CONCLUSIONS: Use of polygeline was associated with an outbreak of fever and hypotension in a SICU. Information from the manufacturer indicated the likelihood of contamination of the product with Bacillus stearothermophilus components. The manufacturer has since changed the production and control processes, and no further adverse events have been seen.

Bacterial Proteins↗
PubMed1990

Reduction of complement activation during bypass by prime manipulation.

Complement activation is believed to be of importance in the development of complications arising after cardiopulmonary bypass. The effect on complement activation of priming the extracorporeal circuit with crystalloid alone, crystalloid plus albumin, or crystalloid plus the plasma expander polygeline was assessed in 36 patients undergoing coronary artery operations with cardiopulmonary bypass using a bubble oxygenator. Activation of the alternative and common complement pathways was monitored before, during, and after the bypass period by measuring concentrations of factor B and its fragment Ba and C3 and its fragment C3d. Complement activation occurred in all three groups of patients, with no difference between the crystalloid and crystalloid-albumin groups. In contrast, Ba fragment concentrations were persistently and significantly lower during and after bypass in the polygeline group, denoting reduced complement activation. C3d levels also showed a tendency to be lower in this group. Our results indicate that addition of polygeline to the priming solution reduces complement activation. Because complement activation is associated with morbidity after cardiopulmonary bypass, addition of polygeline to the priming solution may offer an inexpensive method of reducing morbidity after cardiopulmonary bypass.

Albumins↗
PubMed1988

Decrease of angiotensin-converting enzyme activity after plasma exchange.

We measured sequential changes in serum angiotensin-converting enzyme (ACE) in 12 ICU patients undergoing plasma exchange (PE) with plasma substitutes (albumin-Polygelin). A dramatic decrease in serum ACE activity was observed after each of the 51 PE procedures. Repeated PE procedures resulted in almost a total depletion of serum ACE, which returned to normal ranges in 4 to 10 days. No ACE change was observed during hemodialysis or hemofiltration. ACE activity increased after PE with fresh frozen plasma replacement. ACE changes were compared with IgG, antithrombin III, and fibronectin changes. Extraction ratio comparisons were consistent, with a loss in removed plasma accounting for 50% to 70% of the observed ACE decrease. Plasma zinc levels were not modified after PE. Mixing experiments with increasing volumes of plasma substitutes showed ACE inhibition by Polygelin. In vivo infusion of Polygelin had the same effect. The renin-induced aldosterone response studied in six exchanged patients was consistent with a relative hyperreninemic hypoaldosteronism after repeated PE. These findings may be of clinical relevance during acute hypovolemia and dehydration after PE or Polygelin infusion and in patients with impaired lung endothelial function.

Adult↗
PubMed1982

Prophylaxis of anaphylactoid reactions to a polypeptidal plasma substitute by H1- plus H2-receptor antagonists: synopsis of three randomized controlled trials.

To demonstrate the efficacy of a premedication with H1- + H2-receptor antagonists against histamine-release responses in anaesthesia and surgery 3 randomized controlled trials were conducted in patients, volunteers and experimental animals (dogs). Cutaneous anaphylactoid reactions following infusion of polygeline (Haemaccel) in orthopedic patients were successfully abolished by premedication with 0.1 mg/kg dimethpyrindene (Fenistil) and 5 mg/kg cimetidine (Tagamet). Chlorpheniramine (Piriton) was also useful, but dimethpyrindene was more effective in the doses recommended and used. Side-effects of the premedication were not observed when the 2 drugs were slowly administered (2 min each). Systemic anaphylactoid reactions following infusion of polygeline were completely prevented in volunteers by the same premedication (0.1 mg/kg dimethpyrindene and 10 mg/kg cimetidine). Life-threatening reactions could not be tested in human subjects, but were elicited in experimental animals (dogs). In this species which resembles man in its sensitivity against histamine, in plasma histamine levels and in response to polygeline life-threatening reactions were prevented or in especially severe cases diminished to such an extent by the premedication with H1- + H2-blockers that this premedication was finally judged to be very effective against histamine-release responses of any grade of severity. To confirm this clinically very important hypothesis more clinical trials in patients at risk for anaphylactoid reactions to drugs are urgently needed.

Adult↗
PubMed2001

[Acute "normovolemic" hemodilution with 3.5% polygel (Haemaccel) for patients in the Wertheim-Meigs-operation. Blood loss of 87% blood volume without perioperative blood transfusion].

QUESTION: Is polygeline (Haemaccel) a suitable colloid to perform preoperative acute normovolemic hemodilution (ANH) and to replace a large intraoperative blood loss? METHODS: In a sixty-eight-year-old patient undergoing radical hysterectomy preoperative ANH was performed to a hematocrit of 23% using 3.5% polygeline (Haemaccel). Intraoperative retransfusion of ANH blood was started at a hematocrit of 13%. Plasma volume (indocyanine green-dilution technique) and hematocrit were measured before and after ANH, 3 times intraoperatively (once before retransfusion) and postoperatively. Red cell volume (by labelling erythrocytes with fluorescein) was determined before and after ANH, before retransfusion, and postoperatively. RESULTS: After removal of 1,940 ml of blood and replacement with 15% more of colloid, blood volume decreased by 760 ml. After a mean blood loss of 4,600 ml, 290 ml and 260 ml of red cells were saved due to ANH and use of a cell saver, respectively. CONCLUSIONS: The exact double label measurements of blood volume demonstrated that polygeline, which has a volume effect of only 50%, cannot be considered to be a suitable colloidal substitute during ANH.

Aged↗
PubMed1995

Effect of dextran and enoxaparin on early ePTFE graft thrombogenicity in sheep.

OBJECTIVES: To evaluate the effect of low molecular weight heparin (LMWH), dextran 70 and their combination on platelet adhesion and fibrinogen uptake in ePTFE grafts in an experimental sheep model. DESIGN: Prospective open study. SETTING: Animal Laboratory of a University Hospital. MATERIALS: Early thrombogenicity of ePTFE grafts was studied after interposition in the two common carotid arteries of 40 adult sheep. The animals received one of four different treatment regimens in a double blind randomised way: enoxaparin and polygeline, saline and dextran 70, enoxaparin and dextran 70 or saline and polygeline (control). The substances were administered i.v. with a total dose of 73 antifactor-Xa U/kg for enoxaparin and 1.0 g/kg for dextran 70. Polygeline and saline were used as placebo substances in equivalent volumes. On one side (random allocation) the carotid blood flow was restricted to 25 ml/min, on the other side it was left unrestricted. CHIEF OUTCOME MEASURES: The following variables were studied: 1) fibrinogen uptake; 2) platelet uptake; 3) early graft patency; 4) blood flow in patient grafts; 5) visible presence of graft thrombus; 6) thrombus weight. MAIN RESULTS: The results verified the importance of adequate blood flow as only 30% of grafts with restricted blood flow in the control group were patent compared with 80% of those with unrestricted blood flow (p = 0.038). Dextran 70, enoxaparin and the combination of the two increased early graft patency (p < 0.05) and reduced thrombus weights (p < 0.05) in grafts with restricted blood flow. The relative number of grafts with thrombus free surface was increased in the unrestricted blood flow situation. CONCLUSIONS: Dextran 70 and enoxaparin appeared to be equally effective in decreasing fibrinogen and platelet uptake in the grafts. Their combination was not significantly more effective although there was a favourable trend.

Animals↗
PubMed2002

A prospective randomized study comparing two techniques of perioperative blood conservation: isovolemic hemodilution and hypervolemic hemodilution.

UNLABELLED: We compared hypervolemic hemodilution (HVH) and isovolemic hemodilution (IVH) as means of perioperative blood conservation under standardized conditions. Thirty ASA status I/II adults slated for orthopedic, ear-nose-throat, or general surgery with expected blood loss of >500 mL underwent either IVH (n = 15) or HVH (n = 15). They were hemodiluted to a hematocrit (Hct) of 25% by blood withdrawal and simultaneous polygeline (Hemaccel((R))) infusion (IVH) or by infusing polygeline without blood withdrawal, thus creating hypervolemia (HVH). Further blood loss to a Hct of 20% was allowed before autologous/allogeneic blood transfusion to aim for a 24-h postoperative Hct of > or =25%. Systolic blood pressure (P = 0.0107) and central venous pressure (P = 0.0281) were significantly higher during HVH. The mean difference (MD) between the target postdilution Hct of 25% and the Hct achieved was not statistically significant in either group (MD [95% confidence interval; CI], 0% [-0.7% to 0.7%] for IVH and 0.6% [-0.1% to 1.3%] for HVH). The actual amount of allogeneic blood used was similar in the two groups, with an MD (95% CI) of -7 (-326 to 312), and was significantly less than the corresponding projected amount (MD [95% CI], -581 mL [-753 to -409 mL] in IVH; -376 mL [-531 to -221] in HVH). The two techniques were similar in time taken (MD [95% CI] = 7 min [-0.5 to 14.5 min]), cost incurred (MD [95% CI] = $1.7 (-$4.10 to $7.50]), and volumes of polygeline used (MD [95% CI] = -6 mL/kg body weight [-16 to 4 mL/kg body weight]). This study found IVH and HVH comparable in significantly reducing perioperative allogeneic blood requirements, time needed, and cost incurred. The formula used for achieving the desired HVH appears promising. IMPLICATIONS: Both hypervolemic hemodilution (HVH) and isovolemic hemodilution (IVH) claim to reduce red blood cell loss during surgery by diluting the patient's blood. This study found both comparable in significantly reducing the exposure to bank blood in the perioperative period, the time needed, and the cost incurred. HVH, being simpler, because it does not involve blood withdrawal, appeared superior to IVH in the healthy adults studied. Larger studies are needed to substantiate the results.

Adolescent↗
PubMed2005

A closed system for the clinical banking of umbilical cord blood.

Umbilical cord blood (UCB) is a source of hematopoietic progenitor cells and is used as an alternative to the bone marrow or peripheral blood for treatment of several onco-hematological diseases. Because of the limited number of CD34+ hematopoietic stem cells present in UCB units and of the elevated costs of cryopreservation, it is of paramount importance to select the UCB units that are clinically useful before storage and optimize banking efficiency by designing reliable procedures to process and freeze the selected units. Among the different parameters characterizing UCB, nucleated cell (NC) and CD34+ cell content provides useful criteria to select UCB units since clinical data documented that the infused cell load (both NC and CD34+ cells) plays an important role in the successful outcome of transplants. By evaluating volume, CD34+ cell content, NC total amount, and NC density of 117 UCB units, we found a significant association between CD34+ cell content and NC density and total amount, indicating these parameters as useful to decide UCB clinical utility. Furthermore, we set up a fast procedure to process UCB units for storage. A system for NC separation and volume reduction of UCB samples in a dedicated, germ-free, closed circuit was developed, where plasma and red blood cells (RBC) depletion was obtained by sedimentation in the presence of a 3.5% Polygeline solution. By this separation system, both RBC depletion and high NC and CD34+ cell recoveries were achieved in 60 min, and the yield was comparable to the one obtained by other separation methods. Since Polygeline has been clinically used as a plasma expander and no toxic effects on patients were reported, the protocol can be applied in the large-scale banking of UCB.

Antigens, CD34↗
PubMed1975

Carrier solutions for low-level intravenous insulin infusion.

In the use of low-level intravenous insulin infusion for treating diabetic hyperglycaemia and ketoacidosis adsorption of insulin to containers or plastic infusion apparatus results in significant losses of 60-80% of insulin in dilute physiological saline solution (40 U/l). It is therefore necessary to add protein to the carrier solution to minimize losses and maintain a constant delivery rate. Recovery studies showed that 3.5% w/v polygeline solution (polymer of degraded gelatin) was a suitable medium for this purpose, offering some advantages over human serum albumin. A minimum concentration of 0.5% polygeline was required to ensure adequate delivery of insulin to the patient.

Biological Availability↗
PubMed1983

[Haemaccel 35: adverse reactions in a multicentric, prospective study].

Polygeline (haemaccel 35 Behringwerke) was tested in 1147 patients in a prospective and multicentre study facing systemic anaphylactoid or cutaneous anaphylactoid side effects. 8 patients showed mainly cutaneous reactions (redness and itchy swelling) and only one an increase of ventilating pressure during anaesthesia (0.78%). Polygeline showed according to an improved preparation unexpected reactions only of the cutaneous anaphylactoid type (no severe systemic life threatening reaction, histamine liberation 1 ng/ml or less according to Lorenz).

Adolescent↗
PubMed1980

Incidence and mechanisms of adverse reactions to polypeptides in man and dog.

Adverse reactions (pseudoallergic = anaphylactoid (severe) and allergoid (slight)) to polygeline (Haemaccel) are caused by histamine release. The mechanism by which other polypeptides produce these reactions is unfortunately hitherto unknown. "Purification" of Haemaccel led to a drug which was free from anaphylactoid reactions in a controlled clinical trial. Clinically insignificant allergoid reactions to polygeline (restricted to the skin) could be prevented by premedication with H1 + H2-receptor antagonists.

Anaphylaxis↗
PubMed1993

Acute hyperinsulinemia increases neuropeptide Y concentrations in the hypothalamic arcuate nucleus of fasted rats.

Neuropeptide Y, a major hypothalamic peptide, stimulates feeding, insulin secretion and weight gain when injected intrahypothalamically. Hypothalamic NPY may be regulated by insulin availability at hypothalamic level, as its activity is apparently inhibited by intrahypothalamic insulin administration and is stimulated under insulin-deficient conditions. To determine the effects of acute physiological hyperinsulinemia, we measured regional hypothalamic NPY levels in rats during a hyperinsulinemic, euglycemic clamp. Seven male Wistar rats with implanted jugular cannulae, fasted for 24 h, were infused with insulin at 100 mU/h together with variable-rate glucose to maintain euglycemia (3.9 +/- 0.1 mmol/l), for 150 min. Controls were infused for the same period with polygeline vehicle alone (n = 8), and had blood glucose concentrations of 4.0 +/- 0.5 mmol/l. Insulin levels were 80.2 +/- 3.9 mU/l in insulin-infused rats and 15.2 +/- 1.4 mU/l in polygeline-treated controls (p < 0.001). NPY levels, measured by radioimmunoassay, were significantly higher in the arcuate nucleus/median eminence (ARC/ME) of hyperinsulinemic rats than in controls (4.8 +/- 1.2 vs 2.5 +/- 0.6 fmol/micrograms protein; p < 0.001), but were comparable with controls in 7 other hypothalamic regions. Acute physiological hyperinsulinemia therefore increases NPY levels selectively in the ARC/ME. Insulin could cause NPY accumulation in the ARC by blocking its transport to NPY-sensitive areas. This would be consistent with the suggestions that insulin inhibits hypothalamic NPY activity and also acts as a central satiety factor.

Animals↗