Is targeting an ACT > 400 seconds equivalent compared to an ACT > 480 seconds with respect to PRBC transfusion rates during hospitalization in patients undergoing cardiac surgery with cardiopulmonary bypass?
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Overall packed red blood cell transfusion rate during hospitalization.
Secondary outcome
• 12 and 24-hour blood loss assessed by wound drainage
• Postoperative hemoglobin values at 1, 12 and 24 hours following surgery
• Reoperations due to bleeding
• Late tamponade
• Transfusion requirements (FFP, platelets, fibrinogen, PCC)
• Postoperative hemostatic parameters
• Use of preoperative anticoagulant medication
• Number of patients who do not reach the target ACT after the first heparin
dose
• Total heparin and protamine dosing
• Postoperative restenosis of grafts
• Clotting of the extracorporeal circuit
• Thromboembolic events during and following surgery (e.g. venous thrombosis,
pulmonary embolism)
• Mortality at 30 days, 90 days and 1 year following surgery
• Patient demographics
Background summary
Patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) receive
anticoagulation to inhibit thrombin production, reduce clot formation and
activation of the coagulation system. The amount of anitocoagulant (heparin)
necesary to reach the set target depends on both patient- and procedural
characteristics. Worldwide, but also in the Netherlands, various target
activated clotting time (ACT) values are used during CPB. While part of the
centers use a target ACT > 480 seconds, others use an ACT > 400 seconds. Due to
the lack of large randomized controlled trials in modern cardiosurgical
settings it is unclear which target ACT is associated with the most favorable
hemostatic profile following cardiac surgery.
Study objective
Is targeting an ACT > 400 seconds equivalent compared to an ACT > 480 seconds
with respect to PRBC transfusion rates during hospitalization in patients
undergoing cardiac surgery with cardiopulmonary bypass?
Study design
Multicenter, single-blinded randomized controlled trial.
Intervention
1010 patients undergoing cardiac surgery with cardiopulmonary bypass are
randomized into a group with target ACT >400 seconds or into a group with a
target ACT >480 seconds.
Study burden and risks
Both the use of target ACT values of 400 and 480 seconds for extracorporeal
circulation during cardiosurgical procedures are commonly used in hospitals in
The Netherlands. Participation in this study does not add up to the patiënt
risk. The risks of bleeding and thromboembolic events are currently estimated
as comparable for both study arms, and estimate 2-5% of the patient population
in accordance to routine cardiosurgical practice. Patients who do not
participate in the TACT study will be subjected to an ACT according to the
routine of the local hospital.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Adult patients undergoing elective cardiac surgery with cardiopulmonary bypass
including coronary artery bypass grafting, valve surgery or a combination of
both.
Informed consent.
Exclusion criteria
re-operations
aorta surgery
emergency operation
minimized extracorporeal circuits
deep hypothermia (<32 degrees Celsius)
patients with congenital or aquired coagulation factor abnormatlities
patients with anemia (hemoglobin values < 6.5 mmol/l)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL64741.041.18 |
| OMON | NL-OMON27592 |