Post-Operative Thrombocytopenia After Bio-prosthesis Implantation

Completed

• Conditions: Thrombocytopenia

• Registration Number: NCT03835598
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-02-01
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-08
• Study Start: 2019-06-28
• Status Verified: 2021-03
• Primary Completion: 2021-03-30
• Study Completion: 2021-05-31
• Last Update Submitted: 2021-09-03
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1233

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Platelet count	1-3months follow-up	to evaluate the rate of thrombocytopenia in patients receiving biological prosthesis
Re-exploration for bleeding	From the index procedure up to 3 months	to determine the low platelets-related complication rate
packed Red Cells transfusion, fresh frozen plasma transfusion, Platelet transfusion	During the index hospital stay, an average of 5 days	to determine the low platelets-related complication rate
Major bleeding (requiring more than 2 Red blood cells transfusions)	From the index procedure up to 3 months	to determine the low platelets-related complication rate

Secondary Outcome Measures

Name	Time	Method
Thrombosis	From the index procedure within 3 months	Occurrence of Thrombosis (arterial or venous)
Gastro-intestinal bleeding	From the index procedure within 3 months	Occurrence of gastro-intestinal bleeding
In-hospital mortality	Participants are followed during the duration of hospital stay (expected: up to 7 days post-op)	to assess the in-hospital mortality
In-hospital length of stay	From the index procedure through discharge from the hospital (expected: up to 7 days post-op)	Days after the prosthesis implantation
ICU length of stay	From the index procedure through discharge from the Intensive Care Unit (expected: up to 2 days post op)	Days after the prosthesis implantation
Intracranial Bleeding	From the index procedure within 3 months	Occurrence of intra-cranial bleeding
30-day mortality	within 30 days	Mortality within 30 days

Trial Locations

Locations (1)

Federica Jiritano; 🇳🇱 Maastricht, Netherlands