Polygeline in patients with hypovolemia caused by accidental trauma: a prospective, multicentric, safety study

Sanjay Shah; Ajai Singh; Sanjay Kala; Rohita Shetty

doi:10.18203/2349-2902.isj20181125

Authors

Sanjay Shah Department of Emergency Medicine, CIMS Hospital Care Institute of Medical Sciences, Ahmadabad, Gujarat, India
Ajai Singh Department of Orthopedics, King George’s Medical University, Lucknow, Uttar Pradesh, India
Sanjay Kala Department of Surgery, Ganesh Shankar Vidyarthi Memorial Medical College, Kanpur, Uttar Pradesh, India
Rohita Shetty Senior Medical Advisor, Abbott Healthcare Private Limited, Mumbai, Maharashtra, India

DOI:

https://doi.org/10.18203/2349-2902.isj20181125

Keywords:

Colloids, Hemorrhage, Hypovolemia, Polygeline, Trauma

Abstract

Background: Objective of present study was to evaluate the safety of polygeline (Haemaccel®) and its effect on vital sign parameters in patients with hypovolemia caused by accidental trauma.

Methods: Adverse drug reactions (ADRs) of polygeline within 6 hours after administration, and the effect of polygeline infusion on vital sign parameters, in trauma patients hospitalized at the emergency department, were evaluated in this prospective, multicentric, post-marketing observational study.

Results: One hundred forty patients (men: 81.4%; women: 18.6%), with a mean (±standard deviation) age of 33.7±10.6 years, were enrolled. At the time of admission, mean blood volume loss was 1400.1±558.8ml, with 86.4% patients reporting blood volume loss of >15%; 49.3% patients presented with class-II hypovolemia. No ADRs or any unusual clinically significant changes were reported within 6 hours of polygeline administration. All vital parameters (blood pressure and pulse rate) significantly improved at 1 hour of polygeline administration; this trend was sustained until 6 hours (p<0.001). Reduction in respiratory rate was significant at 1 and 6 hours versus baseline (p<0.001). Urine output and central venous oxygen saturation also showed significant improvement at 1 and 6 hours after treatment initiation (p<0.001). Arterial pH and mean blood lactate levels also showed a significant change from the baseline (p<0.05) at both 1 and 6 hours.

Conclusions: Polygeline was found to be safe and effective in improving hemodynamic stability in patients with hypovolemia due to accidental trauma.

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References

Road accidents in India decrease by 4.1% during 2016, fatalities rise by 3.2%. Press Information Bureau, Government of India, Ministry of Road Transport and Highways. Available at: http://pib.nic.in/newsite/PrintRelease.aspx?relid=170577. Accessed October 20, 2017.

Deane SA, Gaudry PL, Woods P. The management of injuries - a review of deaths in hospital. Aust N Z J Surg. 1988;58:463-9.

American Thoracic Society. Evidence-based colloid use in the critically ill: American Thoracic Society Consensus Statement. Am J Respir Crit Care Med. 2004;170:1247-59.

Brunkhorst FM, Engel C, Bloos F. German Competence Network Sepsis (SepNet). Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med. 2008;358:125-39.

Myburgh JA, Finfer S, Bellomo R. CHEST Investigators; Australian and New Zealand Intensive Care Society Clinical Trials Group. Hydroxyethyl starch or saline for fluid resuscitation in intensive care. N Engl J Med. 2012;367:1901-11.

Annane D, Siami S, Jaber S. Effects of fluid resuscitation with colloids vs crystalloids on mortality in critically ill patients presenting with hypovolemic shock: the CRISTAL randomized trial. JAMA. 2013;310:1809-17.

Bouglé A, Harrois A, Duranteau J. Resuscitative strategies in traumatic hemorrhagic shock. Ann Intensive Care. 2013;3:1.

Evans PA, Garnett M, Boffard K. Evaluation of the effect of colloid (Haemaccel) on the bleeding time in the trauma patient. J R Soc Med. 1996;89:101-4.

Hartog CS, Bauer M, Reinhart K. The efficacy and safety of colloid resuscitation in the critically ill. Anesth Analg. 2011;112:156-64.

Dippenaar JM, Naidoo S. Allergic reactions and anaphylaxis during anesthesia. Curr Allergy Clin Immunol. 2015;28:18-22.

Barron ME, Wilkes MM, Navickis RJ. A systematic review of the comparative safety of colloids. Arch Surg. 2004;139:552-63.

Cherkas D. Traumatic hemorrhagic shock: advances in fluid management. Emerg Med Pract. 2011;13:1-19.

Ahmad M, Adil N. Compatibility and stability of polygeline (Haemaccel) with different drug products. Pak J Pharm Sci. 2014;27:2227-35.

Rossaint R, Bouillon B, Cerny V. Task Force for Advanced Bleeding Care in Trauma. Management of bleeding following major trauma: an updated European guideline. Crit Care. 2010;14:R52.

Bunn F, Trivedi D. Colloid solutions for fluid resuscitation. Cochrane Database Syst Rev. 2012;7:CD001319.

Mitra S, Khandelwal P. Are all colloids same? How to select the right colloid? Indian J Anaesth. 2009;53:592-607.

Adis International. Anaphylactic reaction to Haemaccel (infusion of polymerisate of peptides). Bulletin from SADRAC. 1990;57(4):1-2.

Davies MJ. The role of colloids in blood conservation. Int Anesthesiol Clin. 1990;28:205-9.

Wisborg K. Letter: Anaphylactic reactions induced by infusion of polygeline (haemaccel). Br J Anaesth. 1975;47:1116-7.

Vervloet D, Senft M, Dugue P. Anaphylactic reactions to modified fluid gelatins. J Allergy Clin Immunol. 1983;71:535-40.

Pepys J, Pepys EO, Baldo BA. Anaphylatic/ anaphylactoid reactions to anaesthetic and associated agents. Skin prick tests in aetiological. Anaesthesia. 1994;49:470-5.

Doenicke A, Ennis M, Lorenz W. Histamine release in anesthesia and surgery: a systematic approach to risk in the perioperative period. Int Anesthesiol Clin. 1985;23:41-66.

Weis KH. Haemaccel 35: adverse reactions in a multicentric, prospective study. Anaesthesist. 1983;32:488-93.

Singh A, Ali S. Polygeline in hypovolemia due to traumatic injury: Results of an open label study in Indian population. Int J Crit Illn Inj Sci. 2016;6:21-4.

Singh A, Ali S, Shetty R. Effectiveness and safety of polygeline in patients with hypovolemia due to trauma. J Emerg Trauma Shock. 2017;10:116-20.

Van der Linden P, Ickx BE. The effects of colloid solutions on hemostasis. Can J Anaesth. 2006;53:S30-9.

Orgev B. A trial of a plasma volume expander (haemaccel) in shock. S Afr Med J. 1969;43:1554-6.

Verma RK, Mishra LD, Nath S. Efficacy of polygeline preloading in prevention of hypotension following CSEA. Indian J Anaesth. 2005;49:105-8.

Boldt J. Fluid choice for resuscitation of the trauma patient: a review of the physiological, pharmacological, and clinical evidence. Can J Anaesth. 2004;51:500-513.

Köhler H, Kirch W, Fuchs P. Elimination of hexamethylene diisocyanate cross-linked polypeptides in patients with normal or impaired renal function. Eur J Clin Pharmacol. 1978;14:405-12.

Kaur P, Basu S, Kaur G. Transfusion protocol in trauma. J Emerg Trauma Shock. 2011;4:103-8.

Saddler JM, Horsey PJ. The new generation gelatins. A review of their history, manufacture and properties. Anaesthesia. 1987;42:998-1004.

Cotton BA, Guy JS, Morris JA Jr, et al. The cellular, metabolic, and systemic consequences of aggressive fluid resuscitation strategies.Shock. 2006;26:115-21.