DDAVP Effect by TEG6 in Cardiac Surgery

NCT07179991 | Not Yet Recruiting

• 1 other identifier: DDAVP TEG6
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cardiopulmonary bypass (CPB) is a process that uses a pump that temporarily takes over the function of the heart and lungs during cardiac surgery to maintain blood circulation and oxygenation. Using CPB during cardiac surgery can result in complications with blood clotting. Blood clotting is achieved when molecules in the blood, called platelets, are able to form together with the help of other clotting factors to form a clot. A drug called desmopressin (DDAVP) is used to help blood clot properly by increasing the amount of clotting factors in the blood. Several studies have shown that desmopressin has the ability to reduce the amount of blood transfusions needed for cardiac surgery patients in the postoperative period. At LHSC desmopressin is frequently requested by Cardiac Surgeons and Anesthesiologists to stop bleeding and promote blood clotting where required. A test called TEG6s platelet mapping is a blood test used to help manage the use of blood products by being able to provide information on platelet function and blood clotting activity. At the moment, there is a lack of information regarding the use of TEG6s platelet mapping to analyze the effect of desmopressin on blood clotting in cardiac surgery patients after CPB. The purpose of this study is to investigate the dose-related effects of desmopressin on platelet function in patients undergoing cardiac surgery with CPB. By using TEG6s platelet mapping, this study aims to observe dynamic changes in platelet function following desmopressin administration at various time points in the perioperative and postoperative periods.

Conditions

Intraoperative Bleeding

Keywords

Desmopressin; Cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• Change in platelet function due to desmopressin administration after cardiopulmonary bypass

  This will be measured by TEG6s platelet mapping.

  After arterial line insertion - 24 hours after admission to the intensive care unit

Secondary Outcomes (2)

• Impact of desmopressin on transfusion products required

  After arterial line insertion - 24 hours after admission to the intensive care unit

• Impact of desmopressin on chest drainage

  After arterial line insertion - 24 hours after admission to the intensive care unit

Study Arms (1)

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).

Drug: Desmopressin after protamine reversal

Interventions

Desmopressin after protamine reversal DRUG

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

Desmopressin after protamine reversal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective, observational, single centre study being conducted at London Health Sciences Centre (LHSC) with adults undergoing elective cardiac surgery with cardiopulmonary bypass to investigate the dose-related effects of desmopressin on platelet function in patients undergoing cardiac surgery.

You may qualify if:

• Age 18 years and above
• Undergoing elective cardiac surgery with cardiopulmonary bypass
• Able to provide informed consent

You may not qualify if:

• Hyponatremia
• Allergy to desmopressin or its components
• History of coronary artery disease with thrombosis
• Recent history of thromboembolic events (Stroke/TIA/DVTs)
• Severe Renal Impairment Creatinine Clearance\<30 ml/min
• Inability to communicate in the English language

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Related Publications (15)

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  PMID: 1610009 BACKGROUND

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  PMID: 37645010 BACKGROUND

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  PMID: 24263581 BACKGROUND

• 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.

  PMID: 10408485 BACKGROUND

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  PMID: 32955756 BACKGROUND

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  PMID: 31445833 BACKGROUND

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  PMID: 31179059 BACKGROUND

• 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.

  PMID: 25698197 BACKGROUND

• 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.

  PMID: 1863726 BACKGROUND

• 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.

  PMID: 8560415 BACKGROUND

• 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.

  PMID: 28691229 BACKGROUND

• 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.

  PMID: 34437860 BACKGROUND

• 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.

  PMID: 28537454 BACKGROUND

• 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.

  PMID: 25987196 BACKGROUND

MeSH Terms

Conditions

Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Study Officials

• Satoru Fujii

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Satoru Fujii

CONTACT

5196858500; Satoru.Fujii@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Assistant Professor

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 18, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share