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The Effect of Human Albumin on Coagulation Competence and Hemorrhage

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ClinicalTrials.gov Identifier: NCT02270723
Recruitment Status : Unknown
Verified October 2014 by Kirsten Cleemann Rasmussen, Rigshospitalet, Denmark.
Recruitment status was:  Enrolling by invitation
First Posted : October 21, 2014
Last Update Posted : October 21, 2014
Sponsor:
Information provided by (Responsible Party):
Kirsten Cleemann Rasmussen, Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment Phase
Hemorrhage; Complicating Delivery, Coagulation Defect Drug: 5% Human Albumin " Behring" Drug: Lactated Ringer Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Colloid Versus Crystalloid on Coagulation in Elective Urological Surgery
Study Start Date : August 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Human Albumin " Behring"
Infusion of 5% Human Albumine, maximal 25 ml/kg, is administered intravenously during anaesthesia, duration up to 6 hours
Drug: 5% Human Albumin " Behring"
Intravenous infusion of 5% Human Albumin during major surgery
Other Name: Human Albumin

Placebo Comparator: Lactated Ringer
Infusion of Lactated Ringer solution 25 ml/kg, is administered intravenously during anaesthesia, duration up to 6 hours
Drug: Lactated Ringer
Intravenous infusion of Lactated Ringer during major surgery
Other Name: Ringer




Primary Outcome Measures :
  1. Measurement of coagulation during surgery and in the recovery room [ Time Frame: up to 1 day after surgery ]
    Changes in fibrinogen, platelets, hemoglobin, alpha angle and maximum amplitude


Secondary Outcome Measures :
  1. Measurement of postoperative surgical complications [ Time Frame: From date of operation up to 1 months postoperatvely ]
    Numbers of participants with site infection, postoperative bleeding and leak requiring reoperation

  2. Measurement of hemorrhage and use of blood products during anesthesia and in the recovery room [ Time Frame: up to 1 day after surgery ]
    Volume of lost blood during anesthesia, infusion of blood products, lactated Ringer's and Human Albumin



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270723


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Kirsten Cleemann Rasmussen
Investigators
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Study Chair: Niels H Secher, MD PHD Prof Rigshospitalet, University of Copenhagen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kirsten Cleemann Rasmussen, MD, Specialist in Surgery, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02270723     History of Changes
Other Study ID Numbers: COL18
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: October 21, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hemorrhage
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders