Post-Operative Thrombocytopenia After Bio-prosthesis Implantation

Thrombocytopenia Clinical Trial

— PORTRAIT  

Official title:

Post-Operative Thrombocytopenia After Bio-prosthesis Implantation (PORTRAIT Study): a Retrospective International Multicenter Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03835598
• Other study ID #: NL68980.068.19
• Status: Completed
• Start date: June 28, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: March 2021
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Cardiac surgery is commonly associated with a transient post-operative decrease in the platelet count. Thrombocytopenia after cardiopulmonary bypass can be explained by hemodilution, exposure to artificial surfaces with platelet activation and adhesion, hypothermia, blood loss and mechanical sequestration. It usually occurs between the second and third postoperative days, resulting in a reduction of platelet counts by 40-50% from baseline values. Moreover, when a foreign body as a valve prosthesis is literally placed into the blood flow, blood cells are constantly exposed to its surface and eventually inflammatory and, perhaps, autoimmune reactions could start. The interactions biomaterial-blood induce changes in platelet shape, metabolism as well as receptor-mediated dysfunction and lysis. Then, any significant decline in the circulating platelet count raises concerns about coagulation disorders and bleeding.

Despite the advanced hemodynamic performance, recently thrombocytopenia (defined as nadir platelet count < 150.000 x 1000/uL) has been associated to new aortic biological prostheses, either rapid deployment or trans-catheter valves. Although several studies have been carried on, the drop in the platelet count after aortic valve replacement with certain tissue valves remains unexplained yet. The decrease after the valve implantation, however, is not exclusively limited to the surgical prostheses. Trans-catheter aortic valves, in fact, were found to be associated to post-procedure thrombocytopenia. Thrombocytopenia following transcatheter aortic valve implantation (TAVI) procedures is related to the increased adverse events rate such as death, stroke, acute kidney injury, bleeding and vascular complications. Furthermore, thrombocytopenia seems to occur most likely associated after balloon-expandable valves implantation.The literature, however, is confounding.

Despite several studies, little is known about the mechanism involved. Variations in biocompatibility of valve tissue as like a strong immune/inflammatory response could be some explanations. However, there is still uncertainty about the mechanism conditioning post-operative platelet drop. To address this uncertain the underlying process should be evaluated in a large multicentre trial.

The aims of the study are the following:

• to analyze the occurrence of thrombocytopenia after isolated aortic valve replacement/implantation and after isolated mitral valve replacement;

• to evaluate the clinical impact of thrombocytopenia (length of stay, bleeding, re-operation for bleeding, blood transfusion, mortality).

The study is multicentre, retrospective, observational and will enroll up to 5000 since 2000 to date.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1233
• Est. completion date: May 31, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pre-existent thrombocytopenia;

• Oncologic diseases;

• Pre-existent infections/inflammations;

• Use of drugs inducing thrombocytopenia (<3months);

• Combined cardiac surgery operations;

• Recent percutaneous cardiac intervention (<1month).

Related Conditions & MeSH terms

• Thrombocytopenia

Locations

Country	Name	City	State
Netherlands	Federica Jiritano	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (7)

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. — View Citation

Gallet R, Seemann A, Yamamoto M, Hayat D, Mouillet G, Monin JL, Gueret P, Couetil JP, Dubois-Randé 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet count	to evaluate the rate of thrombocytopenia in patients receiving biological prosthesis	During the index hospital stay, an average of 5 days
Primary	Platelet count	to evaluate the rate of thrombocytopenia in patients receiving biological prosthesis	1-3months follow-up
Primary	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
Primary	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
Primary	Re-exploration for bleeding	to determine the low platelets-related complication rate	From the index procedure up to 3 months
Secondary	In-hospital mortality	to assess the in-hospital mortality	Participants are followed during the duration of hospital stay (expected: up to 7 days post-op)
Secondary	In-hospital length of stay	Days after the prosthesis implantation	From the index procedure through discharge from the hospital (expected: up to 7 days post-op)
Secondary	ICU length of stay	Days after the prosthesis implantation	From the index procedure through discharge from the Intensive Care Unit (expected: up to 2 days post op)
Secondary	Gastro-intestinal bleeding	Occurrence of gastro-intestinal bleeding	From the index procedure within 3 months
Secondary	Intracranial Bleeding	Occurrence of intra-cranial bleeding	From the index procedure within 3 months
Secondary	Thrombosis	Occurrence of Thrombosis (arterial or venous)	From the index procedure within 3 months
Secondary	30-day mortality	Mortality within 30 days	within 30 days