Platelet Inhibition and Bleeding in Patients Undergoing Emergent Cardiac Surgery

Bleeding Clinical Trial

Official title:

Does Platelet Inhibition Predict Surgery Related Bleeding in Patients Undergoing Emergent Cardiac Surgery During Dual Antiplatelet Therapy - a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01468597
• Other study ID #: 21-202 ex 09/10
• Status: Completed
• Start date: January 2011
• Est. completion date: August 2014

Study information

• Verified date: June 2020
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to evaluate if there is an association between platelet inhibition and surgery-related bleeding in patients undergoing emergent cardiac surgery during dual antiplatelet therapy.

Description:

Blood for measuring platelet function is drawn before induction of anesthesia

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• First time on-pump CABG with or without valve replacement

Exclusion Criteria:

• Redo surgery,

• Renal insufficiency needing dialysis,

• Concomitant medication with warfarin,

• Preoperative fibrinogen < 150 mg%

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage

Locations

Country	Name	City	State
Austria	Department of Anesthesiology and Intensive Care Medicine, Department of Surgery, Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculated Blood Loss		until postoperative day 5
Secondary	BARC Bleeding	Intracranial bleed within 48 hours, Reoperation after closure of sternotomy for the purpose of controlling bleeding, Transfusion of equal to or more than 5 Units of packed red blood cells within a 48-hour period, Chest tube output of equal to or more than 2 L within a 24-h period.	until postoperative day 2