Post-Operative Thrombocytopenia After Bio-prosthesis Implantation

NCT03835598 | Completed

• 1 other identifier: NL68980.068.19
• Study Type: observational
• Target: 1,233
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to obtain the clinical data from patients who received a biological prosthesis in aortic or mitral position, in order to evaluate the occurrence of peri-operative thrombocytopenia. The aim of the study is to analyze the eventual clinical impact of the phenomenon (re-operation for bleeding, blood transfusion) and the mortality rate. This is a multicentre retrospective, observentional clinical study. This study will enroll up to 5000 patients since 2000 to date.

Conditions

Thrombocytopenia

Outcome Measures

Primary Outcomes (5)

• Platelet count

  to evaluate the rate of thrombocytopenia in patients receiving biological prosthesis

  During the index hospital stay, an average of 5 days

• Platelet count

  to evaluate the rate of thrombocytopenia in patients receiving biological prosthesis

  1-3months follow-up

• packed Red Cells transfusion, fresh frozen plasma transfusion, Platelet transfusion

  to determine the low platelets-related complication rate

  During the index hospital stay, an average of 5 days

• Major bleeding (requiring more than 2 Red blood cells transfusions)

  to determine the low platelets-related complication rate

  From the index procedure up to 3 months

• Re-exploration for bleeding

  to determine the low platelets-related complication rate

  From the index procedure up to 3 months

Secondary Outcomes (7)

• In-hospital mortality

  Participants are followed during the duration of hospital stay (expected: up to 7 days post-op)

• In-hospital length of stay

  From the index procedure through discharge from the hospital (expected: up to 7 days post-op)

• ICU length of stay

  From the index procedure through discharge from the Intensive Care Unit (expected: up to 2 days post op)

• Gastro-intestinal bleeding

  From the index procedure within 3 months

• Intracranial Bleeding

  From the index procedure within 3 months

Study Arms (1)

Patients with cardiac biological prosthesis

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population is composed by adult patients submitted to isolated aortic valve replacement, percutaneous trans-catheter aortic valve implantation, and mitral valve replacement with a bio-prosthesis.

You may qualify if:

• Patients undergoing isolated aortic valve replacement/implantation or isolated mitral valve replacement with a biological prosthesis.

You may not qualify if:

• Pre-existent thrombocytopenia;
• Oncologic diseases;
• Pre-existent infections/inflammations;
• Use of drugs inducing thrombocytopenia (\<3months);
• Combined cardiac surgery operations;
• Recent percutaneous cardiac intervention (\<1month).

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Federica Jiritano

Maastricht, Netherlands

Location

Related Publications (7)

• Yerebakan C, Kaminski A, Westphal B, Kundt G, Ugurlucan M, Steinhoff G, Liebold A. Thrombocytopenia after aortic valve replacement with the Freedom Solo stentless bioprosthesis. Interact Cardiovasc Thorac Surg. 2008 Aug;7(4):616-20. doi: 10.1510/icvts.2007.169326. Epub 2008 May 27.

  PMID: 18505752 BACKGROUND

• Reents W, Babin-Ebell J, Zacher M, Diegeler A. Thrombocytopenia after aortic valve replacement with the Sorin Freedom Solo prosthesis. J Heart Valve Dis. 2011 May;20(3):313-8.

  PMID: 21714423 BACKGROUND

• Repossini A, Tononi L, Martinil G, Di Bacco L, Girolettiz L, Rosati F, Muneretto C. Platelet activation after sorin freedom solo valve implantation: a comparative study with Carpentier-Edwards Perimount Magna. J Heart Valve Dis. 2014 Nov;23(6):777-82.

  PMID: 25790627 BACKGROUND

• Albacker TB. Thrombocytopenia associated with Perceval sutureless aortic valve replacement in elderly patients: a word of caution. Heart Surg Forum. 2015 Jun 26;18(3):E093-7. doi: 10.1532/hsf.1324.

  PMID: 26115151 BACKGROUND

• Stanger O, Grabherr M, Gahl B, Longnus S, Meinitzer A, Fiedler M, Tevaearai H, Carrel T. Thrombocytopaenia after aortic valve replacement with stented, stentless and sutureless bioprostheses. Eur J Cardiothorac Surg. 2017 Feb 1;51(2):340-346. doi: 10.1093/ejcts/ezw295. No abstract available.

  PMID: 28186236 BACKGROUND

• Gallet R, Seemann A, Yamamoto M, Hayat D, Mouillet G, Monin JL, Gueret P, Couetil JP, Dubois-Rande JL, Teiger E, Lim P. Effect of transcatheter (via femoral artery) aortic valve implantation on the platelet count and its consequences. Am J Cardiol. 2013 Jun 1;111(11):1619-24. doi: 10.1016/j.amjcard.2013.01.332. Epub 2013 Mar 20.

  PMID: 23523059 BACKGROUND

• Jilaihawi H, Doctor N, Chakravarty T, Kashif M, Mirocha J, Cheng W, Lill M, Nakamura M, Gheorghiu M, Makkar RR. Major thrombocytopenia after balloon-expandable transcatheter aortic valve replacement: prognostic implications and comparison to surgical aortic valve replacement. Catheter Cardiovasc Interv. 2015 Jan 1;85(1):130-7. doi: 10.1002/ccd.25430. Epub 2014 Feb 27.

  PMID: 24677617 BACKGROUND

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 8, 2019
• Study Start: June 28, 2019
• Primary Completion: March 30, 2021
• Study Completion: May 31, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-03

Locations

NL (1)