NCT00823082

Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

A Prospective Randomized Pilot Study to Evaluate the Effect of Preoperative Antithrombin Supplementation on Postoperative Levels of Antithrombin in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Instituto Grifols, S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to study the effects of preoperative antithrombin supplementation in patients undergoing cardiac surgery with cardiopulmonary bypass in order to maintain antithrombin levels in a range greater than 58% of functional activity and, eventually, to decrease negative clinical outcomes during the ICU stay.

Conditions

• Acquired Antithrombin III Deficiency
• Coronary Artery Bypass

Interventions

Type	Name	Description
DRUG	Antithrombin III	Single dose of antithrombin III sufficient to achieve a preoperative level of 120%

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-06-01
• Completion: 2011-09-01
• First posted: 2009-01-15
• Last updated: 2016-09-20
• Results posted: 2016-08-04

Locations

1 site across 1 country: Italy