Clinical trial NCT00701142: Haemocomplettan® P During Aortic Replacement
Official title: Haemocomplettan® P in Patients Experiencing Acute Bleeding While Undergoing Aortic Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aortic Aneurysm
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.


Eligibility criteria: Inclusion Criteria:

* Eighteen years of age or older
* Undergoing elective thoracoabdominal aortic replacement surgery (TAAA) or thoracic aortic replacement surgery (TAA)
* Understood and willingly given written informed consent (German language) to participate following an explanation of study background, restrictions, and procedures
* Experience clinically relevant bleeding of the microvasculature following removal of CPB during surgery

Exclusion Criteria:

* Positive pregnancy test, pregnancy or lactation
* Women of child bearing age not using a medically approved method of contraception during the study
* Previous aortic replacement at the same aortic site (redo surgeries)
* Undergoing an emergency operation
* Proof or suspicion of a congenital or acquired coagulation disorder (e.g. VWD or via severe liver disease)
* Myocardial Infarction (MI) or apoplexy in the 2 months preceding study surgery
* ASA administration in the 3 days preceding study surgery, and a pathological (\<74.5 U) ASPI Multiplate® test immediately preceding surgery begin
* Clopidogrel administration in the 5 days preceding study surgery, and a pathological (\<31.1 U) ADP/PG Multiplate® test immediately preceding surgery begin
* Tirofiban administration in the 2 days preceding study surgery, and a pathological (\<94.1 U) TRAP Multiplate® test immediately preceding surgery begin
* Phenprocoumon administration in the 5 days preceding study surgery, and an INR \> 1.28 immediately preceding surgery begin
* Participation in another clinical study in the 4 weeks preceding aortic replacement
* Sensitivity to any of the components of study medication, or to MPs with a similar chemical structure to any of the components of study medication
* Any indication that the restrictions or procedures of the study may not be adhered to (e.g. an uncooperative attitude)
* Any indication that the study restrictions, procedures, or consequences therein have not been considered or understood, such that informed consent cannot be convincingly given
* Multiple morbidities, with a notably constrained remaining length of life

Primary outcomes:
measure: Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects.
timeFrame: From administration of Haemocomplettan® P until 24 hours later
Secondary outcomes:
measure: Proportion of subjects that receive no allogeneic blood products (neither platelets, FFP, nor RBCs)
timeFrame: From administration of Haemocomplettan® P until 24 hours later
measure: Duration of stay in ICU
timeFrame: Last suture of initial surgery to end of ICU stay
measure: Duration of hospital stay
timeFrame: Last suture of initial surgery to end of hospital stay
measure: Mortality
timeFrame: 45 days post surgery
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medical School Hannover (MHH)
Study officials:
affiliation: Abteilung Anästhesiologie, Carl-Neuberg-Strasse 1 / K5, 30177 Hannover
name: Niels Rahe-Meyer, Dr. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahe-Meyer N, Solomon C, Hanke A, Schmidt DS, Knoerzer D, Hochleitner G, Sorensen B, Hagl C, Pichlmaier M. Effects of fibrinogen concentrate as first-line therapy during major aortic replacement surgery: a randomized, placebo-controlled trial. Anesthesiology. 2013 Jan;118(1):40-50. doi: 10.1097/ALN.0b013e3182715d4d.
citation: Rahe-Meyer N, Hanke A, Schmidt DS, Hagl C, Pichlmaier M. Fibrinogen concentrate reduces intraoperative bleeding when used as first-line hemostatic therapy during major aortic replacement surgery: results from a randomized, placebo-controlled trial. J Thorac Cardiovasc Surg. 2013 Mar;145(3 Suppl):S178-85. doi: 10.1016/j.jtcvs.2012.12.083.
citation: Schochl H, Posch A, Hanke A, Voelckel W, Solomon C. High-dose fibrinogen concentrate for haemostatic therapy of a major trauma patient with recent clopidogrel and aspirin intake. Scand J Clin Lab Invest. 2010 Oct;70(6):453-7. doi: 10.3109/00365513.2010.500396.