The Effect of Human Albumin on Coagulation Competence and Hemorrhage

Hemorrhage; Complicating Delivery, Coagulation Defect Clinical Trial

Official title:

Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02270723
• Other study ID #: COL18
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: September 27, 2014
• Last updated: October 17, 2014
• Start date: August 2014
• Est. completion date: November 2015

Study information

• Verified date: October 2014
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

In a randomized clinical trial, the purpose is to investigate if perioperative coagulation and hemorrhage is influenced by colloid or crystalloid.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: November 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemorrhage
• Hemorrhage; Complicating Delivery, Coagulation Defect
• Hemostatic Disorders

Intervention

Drug:
• 5% Human Albumin " Behring"
Intravenous infusion of 5% Human Albumin during major surgery
• Lactated Ringer
Intravenous infusion of Lactated Ringer during major surgery

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Kirsten Cleemann Rasmussen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of coagulation during surgery and in the recovery room	Changes in fibrinogen, platelets, hemoglobin, alpha angle and maximum amplitude	up to 1 day after surgery	Yes
Secondary	Measurement of postoperative surgical complications	Numbers of participants with site infection, postoperative bleeding and leak requiring reoperation	From date of operation up to 1 months postoperatvely	Yes
Secondary	Measurement of hemorrhage and use of blood products during anesthesia and in the recovery room	Volume of lost blood during anesthesia, infusion of blood products, lactated Ringer's and Human Albumin	up to 1 day after surgery	Yes