Study of Coagulation Profile and Role of Heparin Like Effect in Patients With COVID-19

NCT04668404 | Unknown

• 1 other identifier: IEC-04/2020-1641
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection is a pandemic, which has affected approximately 4 lakhs individuals and claimed 16,362 deaths till now. SARS-CoV-2 has been associated with myocarditis and renal dysfunction. Patients hospitalized for Covid-19 severe infection are more prone to excessive coagulation activation leading to thrombotic events both in the venous and arterial circulations, due to excessive inflammation, platelet activation, endothelial dysfunction, and stasis. Nearly 20% of COVID-19 patients present severe coagulation abnormalities, which may occur in almost all of the severe and critical ill COVID-19 cases. Concomitant venous thromboembolism (VTE), a potential cause of unexplained deaths, has been frequently reported in COVID-19 cases, but its management is still challenging due to the complexity between antithrombotic therapy and coagulation disorders. The importance of high D-dimer and Fibrin degradation product level to determine the patient prognostic and the risk of thrombosis is known. In a French study, it was found that a high rate of thromboembolic events in COVID-19 patients treated with therapeutic anticoagulation, with 56% of VTE and 6 pulmonary embolisms. Preliminary reports on COVID-19 patients' clinical and laboratory findings include thrombocytopenia, elevated D-dimer, prolonged prothrombin time, and disseminated intravascular coagulation. COVID-19 patients with acute respiratory failure present a severe hypercoagulability rather than consumptive coagulopathy. Another study highlights this common finding in most COVID-19 patients with high D-dimer levels which are associated with a worse prognosis. Cases showed significantly higher fibrinogen and D-dimer plasma levels versus healthy controls (p \< 0.0001). Markedly hypercoagulable thromboelastometry profiles were observed in COVID-19 patients, as reflected by shorter Clot Formation Time (CFT) in INTEM (p = 0.0002) and EXTEM (p = 0.01) and higher Maximum Clot Firmness (MCF). Fibrin formation and polymerization may predispose to thrombosis and correlate with a worse outcome. Global VE tests provide a more physiologic assessment of coagulation and should be considered to guide blood transfusion requirements in liver transplantation and other major surgery. Its application in patients with Covid19 or in a critical care setting requires more data. Viscoelastic tests, which include TEG, ROTEM, and Sonoclot, offer a means of assessing the activity of pro-and anticoagulant pathways, hyperfibrinolysis, and excessive clot lysis. Assessment of clot formation can be performed in 10 to 20 minutes as a point of care (POC) test; however, assessment of clot lysis takes 30 to 60 minutes. SIRS and sepsis trigger the release of endogenous heparinoids, or a heparin-like effect (HLE), due to small endothelium/mast cell-derived glycosaminoglycan's, which can be detected on heparinase-treated viscoelastic assays. Viscoelastic testing of global coagulation such as thromboelastometry and Sonoclot has been proposed as a superior tool to rapidly diagnose and help guide resuscitation with blood products and anticoagulation. it is deemed necessary to determine the influence of Covid 19 on coagulation parameters using point of care coagulation using sonoclot and conventional coagulation tests. In this prospective trial, the investigators aim to evaluate coagulation abnormalities via traditional tests and whole blood Sonclot profiles in a group of 50 consecutive patients with critically ill COVID-19 patients admitted to the Covid ICU OF Nehru Hospital extension, Postgraduate Institute of Medical Education and Research, Chandigarh.

Conditions

Covid19; Hypercoagulable States Nec

Keywords

COVID-19; Sonoclot; hypercoagulable; ARDS

Outcome Measures

Primary Outcomes (1)

• Correlation of of conventional coagulation tests with point of care coagulation test using sonoclot in COVID-19 patients.

  To correlate conventional coagulation tests with point of care coagulation test using sonoclot

  1 month

Secondary Outcomes (5)

• Clinical Evidence of thrombosis

  1 month

• Coagulation-related Bleeding Event

  28 days

• Presence of Endogenous Heparinoids as demonstrated on POC test [ Time Frame 0, 3 days]

  [ Time Frame 0, 3 days

• Intensive care admission duration

  28 days

• 28 day mortality

  28 days

Study Arms (1)

COVID-19 positive patient with ARDS

All patients with COVID-19 diagnosed with RT-PCR.

Diagnostic Test: Sonoclot

Interventions

Sonoclot DIAGNOSTIC_TEST

Sonoclot machine

COVID-19 positive patient with ARDS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with COVID-19 admitted in ICU/ HDU, admitted under the department of medicine and anaesthesia.

You may qualify if:

• Age 18-80 years
• Confirmed Covid19 patient with positive RT PCR

You may not qualify if:

• Current therapy: Recent blood or blood component transfusion in the last 2 weeks.
• HIV positive/ AIDS patients
• Pregnancy
• Active malignancy within the last 5 years
• Not willing to participate in the study

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, 160012, India

RECRUITING

Related Publications (13)

• Sukriti S, Maras JS, Bihari C, Das S, Vyas AK, Sharma S, Hussain S, Shasthry S, Choudhary A, Premkumar M, Kumar D, Kumar G, Mukhopadhyay C, Kumar A, Trehanpati N, Rautou PE, Moreau R, Sarin SK. Microvesicles in hepatic and peripheral vein can predict nonresponse to corticosteroid therapy in severe alcoholic hepatitis. Aliment Pharmacol Ther. 2018 Apr;47(8):1151-1161. doi: 10.1111/apt.14564. Epub 2018 Feb 20.

  PMID: 29460445 RESULT

• Premkumar M, Bihari C, Saxena P, Devurgowda DR, Vyas T, Mirza R, Jain P, Kumar G, Bhatia P, Baweja S, Choudhury A, Sarin SK. Heparin-like Effect Associated With Risk of Bleeding, Sepsis, and Death in Patients With Severe Alcohol-Associated Hepatitis. Clin Gastroenterol Hepatol. 2020 Feb;18(2):486-495.e3. doi: 10.1016/j.cgh.2019.04.057. Epub 2019 May 8.

  PMID: 31077821 RESULT

• Premkumar M, Devurgowda D, Dudha S, Maiwall R, Bihari C, Grover S, Gupta E, Kumar S, Sarin SK. A/H1N1/09 Influenza is Associated With High Mortality in Liver Cirrhosis. J Clin Exp Hepatol. 2019 Mar-Apr;9(2):162-170. doi: 10.1016/j.jceh.2018.04.006. Epub 2018 May 17.

  PMID: 31024197 RESULT

• Premkumar M, Rangegowda D, Kajal K, Khumuckham JS. Noninvasive estimation of intravascular volume status in cirrhosis by dynamic size and collapsibility indices of the inferior vena cava using bedside echocardiography. JGH Open. 2019 Mar 12;3(4):322-328. doi: 10.1002/jgh3.12166. eCollection 2019 Aug.

  PMID: 31406926 RESULT

• Harzallah I, Debliquis A, Drenou B. Lupus anticoagulant is frequent in patients with Covid-19. J Thromb Haemost. 2020 Aug;18(8):2064-2065. doi: 10.1111/jth.14867. Epub 2020 May 11. No abstract available.

  PMID: 32324958 RESULT

• Panigada M, Bottino N, Tagliabue P, Grasselli G, Novembrino C, Chantarangkul V, Pesenti A, Peyvandi F, Tripodi A. Hypercoagulability of COVID-19 patients in intensive care unit: A report of thromboelastography findings and other parameters of hemostasis. J Thromb Haemost. 2020 Jul;18(7):1738-1742. doi: 10.1111/jth.14850. Epub 2020 Jun 24.

  PMID: 32302438 RESULT

• Lippi G, Plebani M, Henry BM. Thrombocytopenia is associated with severe coronavirus disease 2019 (COVID-19) infections: A meta-analysis. Clin Chim Acta. 2020 Jul;506:145-148. doi: 10.1016/j.cca.2020.03.022. Epub 2020 Mar 13.

  PMID: 32178975 RESULT

• Intagliata NM, Argo CK, Stine JG, Lisman T, Caldwell SH, Violi F; faculty of the 7th International Coagulation in Liver Disease. Concepts and Controversies in Haemostasis and Thrombosis Associated with Liver Disease: Proceedings of the 7th International Coagulation in Liver Disease Conference. Thromb Haemost. 2018 Aug;118(8):1491-1506. doi: 10.1055/s-0038-1666861. Epub 2018 Jul 30. No abstract available.

  PMID: 30060258 RESULT

• Bikdeli B, Madhavan MV, Jimenez D, Chuich T, Dreyfus I, Driggin E, Nigoghossian C, Ageno W, Madjid M, Guo Y, Tang LV, Hu Y, Giri J, Cushman M, Quere I, Dimakakos EP, Gibson CM, Lippi G, Favaloro EJ, Fareed J, Caprini JA, Tafur AJ, Burton JR, Francese DP, Wang EY, Falanga A, McLintock C, Hunt BJ, Spyropoulos AC, Barnes GD, Eikelboom JW, Weinberg I, Schulman S, Carrier M, Piazza G, Beckman JA, Steg PG, Stone GW, Rosenkranz S, Goldhaber SZ, Parikh SA, Monreal M, Krumholz HM, Konstantinides SV, Weitz JI, Lip GYH; Global COVID-19 Thrombosis Collaborative Group, Endorsed by the ISTH, NATF, ESVM, and the IUA, Supported by the ESC Working Group on Pulmonary Circulation and Right Ventricular Function. COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-Up: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Jun 16;75(23):2950-2973. doi: 10.1016/j.jacc.2020.04.031. Epub 2020 Apr 17.

  PMID: 32311448 RESULT

• Fan BE, Chong VCL, Chan SSW, Lim GH, Lim KGE, Tan GB, Mucheli SS, Kuperan P, Ong KH. Hematologic parameters in patients with COVID-19 infection. Am J Hematol. 2020 Jun;95(6):E131-E134. doi: 10.1002/ajh.25774. Epub 2020 Mar 19. No abstract available.

  PMID: 32129508 RESULT

• Cohen AT, Davidson BL, Gallus AS, Lassen MR, Prins MH, Tomkowski W, Turpie AG, Egberts JF, Lensing AW; ARTEMIS Investigators. Efficacy and safety of fondaparinux for the prevention of venous thromboembolism in older acute medical patients: randomised placebo controlled trial. BMJ. 2006 Feb 11;332(7537):325-9. doi: 10.1136/bmj.38733.466748.7C. Epub 2006 Jan 26.

  PMID: 16439370 RESULT

• Kumar M, Ahmad J, Maiwall R, Choudhury A, Bajpai M, Mitra LG, Saluja V, Mohan Agarwal P, Bihari C, Shasthry SM, Jindal A, Bhardwaj A, Kumar G, Sarin SK. Thromboelastography-Guided Blood Component Use in Patients With Cirrhosis With Nonvariceal Bleeding: A Randomized Controlled Trial. Hepatology. 2020 Jan;71(1):235-246. doi: 10.1002/hep.30794. Epub 2019 Aug 27.

  PMID: 31148204 RESULT

• Premkumar M, Loganathan S, Kajal K, Hazarika A, Soni S, Puri GD, Sehgal IS, Suri V, Malhotra P, Singh V, Duseja A, Bhalla A, Ahluwalia J, Kumar N, Kekan K, Ram S, Singla K, Mahajan V, Yaddanapudi N. COVID-19-related dynamic coagulation disturbances and anticoagulation strategies using conventional D-dimer and point-of-care Sonoclot tests: a prospective cohort study. BMJ Open. 2022 May 2;12(5):e051971. doi: 10.1136/bmjopen-2021-051971.

  PMID: 35501097 DERIVED

MeSH Terms

Conditions

COVID-19; Thrombophilia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Kamal KAJAL, MD

CONTACT

+919560412726; kamal.kajal@gmail.com

MADHUMITA PREMKUMAR, DM

CONTACT

+910172256344; drmadhumitap1@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR, DEPT. OF ANAESTHESIA AND INTENSIVE CARE,

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 16, 2020
• Study Start: August 24, 2020
• Primary Completion: January 1, 2021
• Study Completion: February 1, 2021
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)