CompletedPhase 2

Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass

Italy200 participantsStarted 2009-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female * At least 18 years of age * Subject needed elective cardiac surgery with cardiopulmonary bypass except for heart transplantation * Subject had a baseline ATIII level of less than 100% and equal to or above 60% * Subject signed the informed consent form * Subject was willing to comply with all aspects of the protocol, including blood sampling, for the total duration of the study Exclusion Criteria: * Documented congenital ATIII deficiency or ATIII levels below 60% * Subject had a baseline ATIII level of 100% or higher * Subject needed emergency (non-elective) surgery * Subject needed heart transplantation * History of anaphylactic reaction(s) to blood or blood components * Allergies to excipients * Subject was pregnant * Subject had any medical condition that according to the investigators judgment worsens the surgical outcome above the expected * Subject had any medical condition which is likely to interfere with the evaluation of the study treatment and/or the satisfactory conduct of the trial according to the investigators judgment * Subject had participated in any another investigational study within the last 30 days previous to the inclusion

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative ATIII Levels at the ICU Admission

Timeframe: ICU admission

Percentage of Subjects With ATIII Levels of 58% or Higher at ICU Admission

Timeframe: ICU admission

Trial details

NCT IDNCT00823082

SponsorInstituto Grifols, S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-06

Results submitted2016-04-05

View on ClinicalTrials.gov More Acquired Antithrombin III Deficiency trials