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The KyberSept trial
ISRCTN ISRCTN22931023
DOI 10.1186/ISRCTN22931023
ClinicalTrials.gov identifier
EudraCT number
Public title The KyberSept trial
Scientific title
Acronym N/A
Serial number at source N/A
Study hypothesis To determine if high-dose antithrombin III (administered within 6 hours of onset) would provide a survival advantage in patients with severe sepsis and septic shock.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Czech Republic, Denmark, Germany, South Africa, United Kingdom, United States of America
Disease/condition/study domain Sepsis
Participants - inclusion criteria 1. Adult hospitalised men and women (greater than or equal to 18 years)
2. Gave informed consent
3. Met the following criteria within a 6-hour period:
3.1. Clinical evidence of sepsis with a suspected source of infection
3.2. Body temperature (rectal or core) higher than 38.5°C or lower than 35.5°C
3.3. Leukocyte count higher than 10 x 10^3/µL or lower than 3.5 x 10^3/µL
4. Three of the following 6 signs had to be met within the same 6-hour period:
4.1. Tachycardia (heart rate greater than 100/min)
4.2. Tachypnoea (greater than 24/min) or mechanical ventilation because of septic indication
4.3. Hypotension with systolic blood pressure lower than 90 mm Hg despite sufficient fluid replacement or the need of vasoactive agents to maintain systolic blood pressure of 90 mm Hg or greater
4.4. Thrombocytopenia with platelet counts of less than 100 x 103/µL
4.5. Elevated lactate levels (above upper limit of normal range) or metabolic acidosis (pH less than 7.3 or base excess -10 mmol/L) not secondary to respiratory alkalosis
4.6. Oliguria with urine output of less than 20 mL per hour despite sufficient fluid replacement
Participants - exclusion criteria 1. Advanced directive to withhold life-sustaining treatment (except cardiopulmonary resuscitation)
2. Condition other than sepsis anticipated to be fatal within 28 days
3. Pregnancy or breastfeeding
4. History of hypersensitivity to study medication
5. Treatment with other investigational drugs within the last 30 days
6. Treatment with an antithrombin III concentrate within the last 48 hours
7. Treatment with heparin (except subcutaneous low dose or intravenous [IV] line flushing) or coumarin derivatives
8. Non-steroidal anti-inflammatory drug treatment within previous 2 days
9. Known bleeding disorder or ongoing massive surgical bleeding
10. Platelet count of less than 30 x 10^3/µL
11. Immunocompromised status
12. Acute myocardial infarction (within previous 7 days)
13. Third-degree burns (20% of total body area)
14. Incurable malignancy with documented metastases and life-expectancy of less than 3 months
15. Haematologic neoplasia during cytostatic treatment
16. Bone marrow aplasia
17. Preexisting dialysis-dependent renal failure
18. End-stage liver disease
19. Transplantation (postoperative state)
20. History of stroke within the last year
21. Severe cranial or spinal trauma within the last year
22. Planned cranial or spinal surgery (except nontraumatic lumbar puncture) within the next 48 hours
Anticipated start date 01/03/1997
Anticipated end date 01/01/2000
Status of trial Completed
Patient information material
Target number of participants 2,314
Interventions Patients were randomly assigned to receive 30 000 IU antithrombin III (Aventis Behring, Marburg, Germany) with a loading dose of 6000 IU (given over 30 minutes), followed by a continuous IV infusion of 6000 IU per day for 4 days, or an equivalent volume of placebo solution (1% of human albumin).
Primary outcome measure(s) 28-day all-cause mortality in the primary efficacy population.
Secondary outcome measure(s) 1. Survival time within 7 days
2. Length of intensive care unit stay within 7 days
3. Occurrence of new organ dysfunction (according to Logistic Organ Dysfunction score) within 7 days
4. Severity of sepsis was assessed via the Simplified Acute Physiology Score version II(SAPS II)
5. Surgical interventions and bleeding events, recorded for 28 days
6. Other serious adverse events, recorded for 14 days
7. Antithrombin III plasma concentrations (functional) at baseline and after 24 hours
8. Activated partial thromboplastin time and prothrombin time values, assessed at baseline and 3 times daily for days 1 through 5 and on day 7
Sources of funding Aventis Behring LLC (USA)
Trial website
Publications 1. 2001 Results in http://www.ncbi.nlm.nih.gov/pubmed/11597289
2. 2002 Quality of life evaluation: http://www.ncbi.nlm.nih.gov/pubmed/12225612
3. 2006 Results in http://www.ncbi.nlm.nih.gov/pubmed/17107615
Contact name Mr  Dale  Rublee
  Address Aventis Behring LLC
1020 First Avenue
PO Box 61501
  City/town King of Prussia
  Zip/Postcode PA 19406
  Country United States of America
  Tel +1 610 878 4833
  Fax +1 610 878 4086
  Email dale.rublee@aventis.com
Sponsor Aventis Behring LLC (USA)
  Address 1020 First Avenue
PO Box 61501
  City/town King of Prussia
  Zip/Postcode 61501
  Country United States of America
  Sponsor website: http://www.cslbehring.com/
Date applied 05/06/2002
Last edited 15/11/2013
Date ISRCTN assigned 05/06/2002
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