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Comparison Between Return and Wastage of Your Own Blood, Collected During Spinal Surgery, for Verification of Safety When Returning Blood

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wellspect HealthCare
ClinicalTrials.gov Identifier:
NCT01251042
First received: September 24, 2010
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

The study is an open, randomized, controlled, single-centre study including a total of 42 evaluable subjects scheduled for spinal surgery with an approximate expected bleeding of 800-1500 ml. The Sangvia® Blood Salvage System will be set up for all subjects to collect blood intra-operatively. When the transfusion bag is filled, i.e. when around 500 ml of blood has been collected, the subject will be randomized to either be retransfused with the blood collected (investigational group) or not (control group). The primary objective for this study is to investigate the blood quality and isolate the systemic effects in intra-operatively collected blood. The systemic p-Hb concentration has been chosen as the primary outcome variable based on previous experience and literature and is considered as the major safety concern for the study subjects.


Condition Intervention
Spinal Surgery
Device: Sangvia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Study on Intra-operative Autologous Transfusion With the Sangvia® Blood Salvage System in Spinal Surgery

Resource links provided by NLM:


Further study details as provided by Wellspect HealthCare:

Primary Outcome Measures:
  • Difference in Plasma Free Hemoglobin (p-Hb) Concentration [ Time Frame: At screening and 24 hours after surgery (surgery takes place 1-7 days after screening) ] [ Designated as safety issue: Yes ]
    Difference in plasma free hemoglobin (p-Hb) concentration between screening and 24 hours after surgery


Secondary Outcome Measures:
  • Plasma Free Hemoglobin (p-Hb) Concentration [ Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) ] [ Designated as safety issue: Yes ]
    Systemic plasma free hemoglobin (p-Hb) concentration from screening until 96 hours after surgery.

  • Hemoglobin Concentration [ Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) ] [ Designated as safety issue: Yes ]
    Systemic hemoglobin concentration from screening until 96 hours after surgery.

  • Potassium Concentration [ Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) ] [ Designated as safety issue: Yes ]
    Systemic potassium concentration from screening until 96 hours after surgery.

  • Creatinine Concentration [ Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) ] [ Designated as safety issue: Yes ]
    Systemic creatinine concentration from screening until 96 hours after surgery.

  • Interleukin-1-alpha (IL-1-α) Concentration [ Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) ] [ Designated as safety issue: Yes ]
    Systemic IL-1-α concentration from screening until 96 hours after surgery.

  • Interleukin-6 (IL-6) Concentration [ Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) ] [ Designated as safety issue: Yes ]
    Systemic IL-6 concentration from screening until 96 hours after surgery.

  • Interleukin-8 (IL-8) Concentration [ Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) ] [ Designated as safety issue: Yes ]
    Systemic IL-8 concentration from screening until 96 hours after surgery.

  • Interleukin-10 (IL-10) Concentration [ Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) ] [ Designated as safety issue: Yes ]
    Systemic IL-10 concentration from screening until 96 hours after surgery.

  • Tumor Necrosis Factor Alpha (TNF-α) Concentration [ Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) ] [ Designated as safety issue: Yes ]
    Systemic TNF-α concentration from screening until 96 hours after surgery.

  • Interferon Gamma (IFN-γ) Concentration [ Time Frame: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening) ] [ Designated as safety issue: Yes ]
    Systemic IFN-γ concentration from screening until 96 hours after surgery.

  • Mean Blood Loss Volume [ Time Frame: After surgery (surgery takes place 1-7 days after screening) ] [ Designated as safety issue: No ]
    Estimated blood loss during and after surgery.

  • Frequency of Allogenic Blood Transfusion [ Time Frame: Up until 96 hours after surgery (surgery takes place 1-7 days after screening) ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: October 2010
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sangvia and retransfusion Device: Sangvia
The Sangvia® Blood Salvage System used to collect blood intra-operatively.
Sham Comparator: Sangvia and no retransfusion Device: Sangvia
The Sangvia® Blood Salvage System used to collect blood intra-operatively.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of informed consent.
  • Male and female subjects aged 18 years and over subjected to spinal surgery with an approximate expected bleeding of 800-1500 ml.
  • Subjects classified as ASA Physical Status Classification System class P1, P2 or P3 according to the American Society of Anaesthesiology.

Exclusion Criteria:

  • Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study site).
  • Previous enrolment or randomisation of treatment in the present study.
  • Participation in another clinical study, that may interfere with the present study.
  • Severe non-compliance to protocol as judged by the investigator and/or Astra Tech.
  • Haemophilia.
  • Hyperkalemia (i.e. values above the normal reference values at study site).
  • Symptoms of impaired renal function including creatinine clearance levels (using the Cockcroft-Gault formula) <30 ml/min.
  • Malignancy in the area of the operative site.
  • Current or expected use of cytotoxic drugs.
  • Symptoms of systemic infection or local infection in the operation field.
  • Pregnancy.
  • Sickle cell anaemia and/or pre-operative Hb concentration <11 g/dl (6,8 mmol/l).
  • Use of recombinant erythropoietin (EPO) or fibrin sealant.
  • Use of other autologous blood transfusion than with the Sangvia® system (e.g. CellSaver and pre-donation) or other blood saving techniques (e.g. normovolemic hemodilution).
  • Hypotensive anesthesia.
  • Use of antithrombotic medication within 5 days of surgery (NSAID, Clopidogrel).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251042

Locations
Denmark
Clinical Trial Unit, Glostrup Hospital, University of Copenhagen
Glostrup, Denmark
Sponsors and Collaborators
Wellspect HealthCare
Investigators
Principal Investigator: Michael Rud Lassen, MD Glostrup Hospital, University of Copenhagen
  More Information

No publications provided

Responsible Party: Wellspect HealthCare
ClinicalTrials.gov Identifier: NCT01251042     History of Changes
Other Study ID Numbers: YA-DRA-0006
Study First Received: September 24, 2010
Results First Received: March 12, 2013
Last Updated: April 29, 2013
Health Authority: Denmark: Ethics Committee

ClinicalTrials.gov processed this record on November 25, 2014