Study Results
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Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2025-10-01
2027-12-31
Brief Summary
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Detailed Description
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Viscoelastic testing, specifically TEG (Thromboelastography) platelet mapping and TEG6s and have been shown to be helpful in managing the use of blood products, fresh frozen plasma (FFP), platelets and fibrinogen, in coagulopathic patient post cardiopulmonary bypass. Desmopressin is given at a dose 0.3 micrograms/kg intravenously over 15 to 30 minutes as a standard dose in cardiac surgery, up to 20 mcg which is the United States Food and Drug Administration (US FDA) recommended dose for Hemophilia treatment and the most commonly cited dose used in cardiac surgery after cardiopulmonary bypass. The TEG6s platelet mapping shows baseline platelet function and receptor-specific platelet function and inhibition. This assessment is based on four different assays including Koalin, Activator F, ADP (Adenosine Diphosphate), AA (Arachidonic Acid). At the current time there is limited literature looking at the qualitative effect of desmopressin on platelet function using TEG6s platelet mapping analysis. The purpose of this study is to investigate the dose-related effects of desmopressin on platelet function in patients undergoing cardiac surgery. By using TEG6s platelet mapping we aim to observe dynamic changes in platelet function following desmopressin administration at various time points in perioperative and postoperative periods.
Informed, written consent will be obtained prior to the start of surgery.
Participants that are enrolled in this study will have their surgery proceed according to plan and will be placed under general anesthesia using standard of care practices. Cardiopulmonary bypass will be implemented in accordance with standard of care practices. Desmopressin will be given to participants at a dose of 0.3mcg/kg, up to 20 mcg after protamine reversal at the end of cardiopulmonary bypass.
Platelet function will be assessed by TEG platelet mapping at the following points:
1. T1 TEG6s: after arterial line insertion before skin incision.
2. T2 TEG6s: after protamine (baseline function after CPB)
3. T3 TEG6s: 30 minutes after desmopressin
4. T4 TEG6s: 6 hours after (intensive care unit) ICU admission
5. T5 TEG6s: 24hours after ICU admission
This will involve drawing 4 ml of blood from patients at each of the above time points (5 blood draws total), in a dark green-top (Sodium Heparin) Vacutainer® tube by the Cardiac Anesthesiologist who will be also running the test on the TEG Machine. The study team will also collect information such as participant age, biological sex, height, weight, medications, medical history, surgical details, results of preoperative and postoperative blood work, and details of their postoperative recovery.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Desmopressin after protamine reversal
Desmopressin will be given to participants at a dose of 0.3mcg/kg after protamine reversal at the end of cardiopulmonary bypass (CPB).
Desmopressin after protamine reversal
Desmopressin will be given to participants at a dose of 0.3mcg/kg after protamine reversal at the end of cardiopulmonary bypass (CPB).
Platelet function will be assessed by TEG (Thromboelastography) platelet mapping at the following points:
1. T1 TEG6s: after arterial line insertion before skin incision.
2. T2 TEG6s: after protamine (baseline function after CPB)
3. T3 TEG6s: 30 minutes after desmopressin
4. T4 TEG6s: 6 hours after (intensive care unit) ICU admission
5. T5 TEG6s: 24hours after ICU admission
Interventions
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Desmopressin after protamine reversal
Desmopressin will be given to participants at a dose of 0.3mcg/kg after protamine reversal at the end of cardiopulmonary bypass (CPB).
Platelet function will be assessed by TEG (Thromboelastography) platelet mapping at the following points:
1. T1 TEG6s: after arterial line insertion before skin incision.
2. T2 TEG6s: after protamine (baseline function after CPB)
3. T3 TEG6s: 30 minutes after desmopressin
4. T4 TEG6s: 6 hours after (intensive care unit) ICU admission
5. T5 TEG6s: 24hours after ICU admission
Eligibility Criteria
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Inclusion Criteria
2. Undergoing elective cardiac surgery with cardiopulmonary bypass
3. Able to provide informed consent
Exclusion Criteria
2. Allergy to desmopressin or its components
3. History of coronary artery disease with thrombosis
4. Recent history of thromboembolic events (Stroke/TIA/DVTs)
5. Severe Renal Impairment Creatinine Clearance\<30 ml/min
6. Inability to communicate in the English language
18 Years
ALL
No
Sponsors
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Satoru Fujii
Anesthesiologist, Assistant Professor
Principal Investigators
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Satoru Fujii
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre
Central Contacts
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References
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Mongan PD, Hosking MP. The role of desmopressin acetate in patients undergoing coronary artery bypass surgery. A controlled clinical trial with thromboelastographic risk stratification. Anesthesiology. 1992 Jul;77(1):38-46. doi: 10.1097/00000542-199207000-00007.
Ozkisacik E, Islamoglu F, Posacioglu H, Yagdi T, Basarir S, Omay SB, Ozbaran M, Buket S. Desmopressin usage in elective cardiac surgery. J Cardiovasc Surg (Torino). 2001 Dec;42(6):741-7.
Jahangirifard A, Mirtajani SB, Madadi F. Effect of Desmopressin on Bleeding After Heart Surgeries: A Narrative Review. Anesth Pain Med. 2023 Mar 10;13(2):e133894. doi: 10.5812/aapm-133894. eCollection 2023 Apr.
Wademan BH, Galvin SD. Desmopressin for reducing postoperative blood loss and transfusion requirements following cardiac surgery in adults. Interact Cardiovasc Thorac Surg. 2014 Mar;18(3):360-70. doi: 10.1093/icvts/ivt491. Epub 2013 Nov 21.
Despotis GJ, Levine V, Saleem R, Spitznagel E, Joist JH. Use of point-of-care test in identification of patients who can benefit from desmopressin during cardiac surgery: a randomised controlled trial. Lancet. 1999 Jul 10;354(9173):106-10. doi: 10.1016/S0140-6736(98)12494-7.
Agarwal S, Abdelmotieleb M. Viscoelastic testing in cardiac surgery. Transfusion. 2020 Oct;60 Suppl 6:S52-S60. doi: 10.1111/trf.16075. Epub 2020 Sep 21.
Meco M, Montisci A, Giustiniano E, Greco M, Pappalardo F, Mammana L, Panisi P, Roscitano C, Cirri S, Donatelli F, Albano G. Viscoelastic Blood Tests Use in Adult Cardiac Surgery: Meta-Analysis, Meta-Regression, and Trial Sequential Analysis. J Cardiothorac Vasc Anesth. 2020 Jan;34(1):119-127. doi: 10.1053/j.jvca.2019.06.030. Epub 2019 Jun 28.
Li C, Zhao Q, Yang K, Jiang L, Yu J. Thromboelastography or rotational thromboelastometry for bleeding management in adults undergoing cardiac surgery: a systematic review with meta-analysis and trial sequential analysis. J Thorac Dis. 2019 Apr;11(4):1170-1181. doi: 10.21037/jtd.2019.04.39.
Jin L, Ji HW. Effect of desmopressin on platelet aggregation and blood loss in patients undergoing valvular heart surgery. Chin Med J (Engl). 2015 Mar 5;128(5):644-7. doi: 10.4103/0366-6999.151663.
Salmenpera M, Kuitunen A, Hynynen M, Heinonen J. Hemodynamic responses to desmopressin acetate after CABG: a double-blind trial. J Cardiothorac Vasc Anesth. 1991 Apr;5(2):146-9. doi: 10.1016/1053-0770(91)90328-q.
Cattaneo M, Harris AS, Stromberg U, Mannucci PM. The effect of desmopressin on reducing blood loss in cardiac surgery--a meta-analysis of double-blind, placebo-controlled trials. Thromb Haemost. 1995 Oct;74(4):1064-70.
Desborough MJ, Oakland K, Brierley C, Bennett S, Doree C, Trivella M, Hopewell S, Stanworth SJ, Estcourt LJ. Desmopressin use for minimising perioperative blood transfusion. Cochrane Database Syst Rev. 2017 Jul 10;7(7):CD001884. doi: 10.1002/14651858.CD001884.pub3.
Rogers AL, Allman RD, Fang X, Kindell LC, Nifong LW, Degner BC, Akhter SA. Thromboelastography-Platelet Mapping Allows Safe and Earlier Urgent Coronary Artery Bypass Grafting. Ann Thorac Surg. 2022 Apr;113(4):1119-1125. doi: 10.1016/j.athoracsur.2021.07.068. Epub 2021 Aug 24.
Sivapalan P, Back AC, Ostrowski SR, Ravn HB, Johansson PI. Transfusion requirements in elective cardiopulmonary bypass surgery patients: predictive value of Multiplate and Thromboelastography (TEG) Platelet Mapping Assay. Scand J Clin Lab Invest. 2017 Sep;77(5):345-351. doi: 10.1080/00365513.2017.1325000. Epub 2017 May 24.
Agarwal S, Johnson RI, Kirmani BH. Pre- and Post-Bypass Platelet Function Testing With Multiple Electrode Aggregometry and TEG Platelet Mapping in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2015 Oct;29(5):1272-6. doi: 10.1053/j.jvca.2015.01.028. Epub 2015 Jan 16.
Other Identifiers
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DDAVP TEG6
Identifier Type: -
Identifier Source: org_study_id
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