Clinical trial NCT02270723: The Effect of Human Albumin on Coagulation Competence and Hemorrhage
Official title: Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hemorrhage; Complicating Delivery, Coagulation Defect
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 40
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: In a randomized clinical trial, the purpose is to investigate if perioperative coagulation and hemorrhage is influenced by colloid or crystalloid.

Detailed description: 5% Human Albumin is used for fluid therapy during surgery. This study evaluate whether affected coagulation competence induced by Human Albumin leads to a significant perioperative blood loss when compared to administration of lactated Ringer´s solution.

Data are gathered by the investigators, analysed by the sponsor, and remain confidential throughout the process. The investigators shall be involved in all stages of the study development and vouch for the completeness and accuracy of the data. No third part shall influence the protocol, trial conduct, data analysis, or reporting.

The investigators will include 40 patients undergoing cystectomy. Heart rate, mean arterial pressure, cardiac output are measured after induction of anaesthesia and insertion of the arterial catheter (T0), after establishing normovolaemia but before surgery (T1), after resection of the urinary bladder (T2), at the end of the surgery (T3), and two hours thereafter in the recovery room (T4).

Arterial blood is drawn for whole blood viscoelastic haemostatic assays to record clot initiation (R-Time), formation (Maximal Amplitude, MA), alpha angle(α) and lysis (Ly30) depicting haemostatic competence (thrombelastography). The investigators analyze blood for haemoglobin, creatinine, platelets, and fibrinogen. Furthermore, blood is drawn from the central venous catheter for lactate and blood gas variables (ABL 825, Radiometer, Copenhagen, Denmark). To avoid excessive administration of Human Albumin, patients receive lactated Ringer´s solution if considered needed after the infusion 25 mL/kg of the allocated fluid (non-study fluid).

The fluid balance inclusive the blood loss was calculated after cystectomy, at the end of surgery, and two hours thereafter. The investigators register complications postoperatively inclusive hospital stay until discharge.

Eligibility criteria: Inclusion Criteria:

* Patient more than 18 years old
* Indication for elective post-renal operation including cystectomy
* Patient without anticoagulative, acetylsalicylic acid or nonsteroidal antiinflammatory drug

treatment for the last 5 days

Exclusion Criteria:

* Intracerebral bleeding, manifest cardiac insufficient, renal insufficient demanding dialysis, hepatic or coagulation diseases
* Pregnant or nursing
* Allergic to Human Albumin
* Disturbance in electrolytes
* Patient under committee
* Patient joining another trial interfering the actual trial

Primary outcomes:
measure: Measurement of coagulation during surgery and in the recovery room
timeFrame: up to 1 day after surgery
Secondary outcomes:
measure: Measurement of postoperative surgical complications
timeFrame: From date of operation up to 1 months postoperatvely
measure: Measurement of hemorrhage and use of blood products during anesthesia and in the recovery room
timeFrame: up to 1 day after surgery
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, University of Copenhagen
name: Niels H Secher, MD PHD Prof
role: STUDY_CHAIR
References:
citation: Rasmussen KC, Hojskov M, Johansson PI, Kridina I, Kistorp T, Salling L, Nielsen HB, Ruhnau B, Pedersen T, Secher NH. Impact of Albumin on Coagulation Competence and Hemorrhage During Major Surgery: A Randomized Controlled Trial. Medicine (Baltimore). 2016 Mar;95(9):e2720. doi: 10.1097/MD.0000000000002720.