|- candidate number||5515|
|- NTR Number||NTR1738|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-mrt-2009|
|- Secondary IDs||2007.124 MEC UMCG|
|- Public Title||Een vergelijking van twee meetmethoden voor de mate van ontstolling gedurende cardiopulmonale bypass tijdens hartchirurgie.|
|- Scientific Title||Comparison of celite activated clotting time with kaolin activated clotting time on heparin use during cardiac surgery.|
|- hypothesis||We recently found that the longterm use of aspirin resulted in lower celite-ACT during cardiopulmonary bypass (CPB). The ACT is routinely measured in duplicate. A review of patient charts suggests that kaolin-ACT has less variability than celite ACT. We hypothesize that kaolin guided ACT management results in less heparin use. |
|- Healt Condition(s) or Problem(s) studied||Cardiopulmonary Bypass (CPB), Cardiac surgery|
|- Inclusion criteria||Patients presenting for coronary artery bypass grafting and/or valve repair/replacement.|
|- Exclusion criteria||Excluded are patients with heredetary coagulopathies, patients pre-operatively treated with unfractionated heparin, patients treated with aprotinin, and patients less than 18 years old. |
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2008|
|- planned closingdate||1-sep-2009|
|- Target number of participants||100|
|- Interventions||Group one: heparin management is guided by celite-ACT.|
Group two: heparin management is guided by kaolin-ACT.
To measure the actual heparin concentration a duplicate HiTT (high dose thrombin time) measurement will also be perfomed (3mL).
1. Preoperative and postoperative antithrombin-3 (3mL);
2. End cpb fibrinopeptide a (3mL);
3. Postoperative chest tube loss;
4. Use of blood and bloodproducts;
5. Length of stay in the ICU.
|- Primary outcome||Total heparin use at the end of CPB.|
|- Secondary outcome||1. Fibrinopeptide A concentration; |
2. Postoperative chest tube loss;
3. Use of blood and blood products;
4. Length of stay in the intensive care unit.
|- Timepoints||After induction of anesthesia baseline ACT is measured. Heparin is given before CPB as usual (300IU/kg). After 3 min ACT is measured as usual. If ACT<400s addiitonal heparin (100IU/kg) is given. 5 min after start CPB and then after every 30 min ACT is measured as usual. If ACT<400s addiitonal heparin (100IU/kg) is given according to our clinical practice. After CPB the heparin is neutralized with protamine in a 1:1 ratio as usual.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. A.J. Vries, de|
|- CONTACT for SCIENTIFIC QUERIES||Drs. A.J. Vries, de|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG)|
|- Brief summary||Rationale:|
During cardiac surgery a sufficient anticoagulation is necessary for the period of cardiopulmonary bypass (CPB). Heparin is used for this purpose. Anticoagulation is point of care monitored using the activated clotting time (ACT) as described by Bull . As activator for this measurement either celite or kaolin is used. Both activators are used routinely in clinical practice. In this hospital both measurements are also used. However, there is doubt about the consequences of heparin management using these measurements. Moreover, a review of patient charts suggests that kaolin ACT has less variability than celite ACT.
In this study we will therefore measure total heparin use and the concentration of fibrinopeptide A at the end of CPB, using either celite ACT or kaolin ACT guided heparin management. In addidtion clinical parameters as chest tube loss, blood use, and length of stay in the intensive care unit will be measured. We propose this study also to compare duplicate measurements of celite ACT with duplicate measurements of kaolin ACT in patients undergoing cardiac surgery.
Prospective randomized clinical trial.
Patients presenting for cabg and/or valve reair/replacement. Excluded are patients with heredetary coagulopathies, patients pre-operatively treated with unfractionated heparin, patients less than 18 years old.
Group one: heparin management for CPB is guided by celite ACT.
Group two: heparin management for CPB is guided by kaolinACT.
Main study parameters/endpoints:
Primary: the total amount of heparin given in each group.
Secondary: Fibrinopeptide A concentration; postoperative chest tube loss, use of blood and blood products, and length of stay in the intensive care unit.
|- Main changes (audit trail)|
|- RECORD||26-mrt-2009 - 23-sep-2009|