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Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anaemia Due to Angiodysplasias (OCEAN)

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ClinicalTrials.gov Identifier: NCT02384122
Recruitment Status : Unknown
Verified April 2018 by Radboud University.
Recruitment status was:  Recruiting
First Posted : March 10, 2015
Last Update Posted : April 19, 2018
Sponsor:
Collaborators:
St. Antonius Hospital
Jeroen Bosch Ziekenhuis
VU University Medical Center
Catharina Ziekenhuis Eindhoven
Elisabeth-TweeSteden Ziekenhuis
Gelre Hospitals
Reinier de Graaf Groep
Bernhoven Hospital
Information provided by (Responsible Party):
Radboud University

Tracking Information
First Submitted Date  ICMJE March 4, 2015
First Posted Date  ICMJE March 10, 2015
Last Update Posted Date April 19, 2018
Study Start Date  ICMJE September 2015
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2015)
The mean difference in blood and iron requirements. [ Time Frame: Comparing the one year before inclusion and the study period (until week 52) ]
The mean/median difference in blood and iron requirements between the one year prior to inclusion and the treatment period of one year compared between the intervention and control arm. All blood transfusions that are given with another indication than gastrointestinal blood loss are registered, but excluded for analysis for the primary outcome.
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2015)
Change in units of blood and iron infusion [ Time Frame: From a half year before inclusion in the study until end of treatment visit (week 48) ]
The mean/median difference in units of transfused red blood cells and iron infusions between the half year before inclusion and the treatment period comparing the Sandostatin with the placebo arm. All blood transfusions that are given with another indication than gastrointestinal blood loss are registered, but excluded for analysis for the primary outcome.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2015)
  • Percentage of hemoglobin increase from baseline until end of treatment visit. [ Time Frame: From inclusion in the study until end of treatment visit (week 48). ]
    Change in haemoglobin level comparing the octreotide the control arm, as assessed as slope through all haemoglobin measurements taken at study visits during the treatment phase.
  • Number of patients requiring red blood cell transfusions [ Time Frame: From inclusion in the study until end of treatment (week 52). ]
    Comparing the octreotide with the control arm.
  • The mean difference in hemoglobin level [ Time Frame: From inclusion in the study until end of treatment visit (week 48). ]
    Comparing the octreotide with the control arm.
  • Change in number and severity of bleeding episodes [ Time Frame: From inclusion in the study until end of treatment visit (week 52). ]
    Comparing the octreotide with the control arm.
  • Number of patients free of rebleeding [ Time Frame: The year prior to inclusion compared to the treatment period of one year (week 52). ]
    Comparing the octreotide with the control arm.
  • The number and type of adverse events [ Time Frame: From inclusion in the study until last follow-up visit (week 60). ]
    Comparing the octreotide with the control arm.
  • Difference in number of hospitalizations, ICU admissions and duration of hospitalization [ Time Frame: The year prior to inclusion compared to the treatment period of one year (week 52). ]
    Comparing the octreotide with the control arm.
  • Difference in need for rescue therapy [ Time Frame: The year prior to inclusion compared to the treatment period of one year (week 52). ]
    Comparing the octreotide with the control arm for use of argon plasma coagulation, coiling or surgery.
  • Mortality and cause of death [ Time Frame: From inclusion in the study until last follow-up visit (week 60). ]
    Comparing the octreotide with the control arm.
  • Difference in quality of life [ Time Frame: From inclusion in the study until last follow-up visit (week 60). ]
    Quality of Life as measured by SF36 and PSQ-An questionnaire. Comparing the octreotide with the control arm.
  • Number of patients requiring other transfusions or medication to correct coagulation [ Time Frame: From baseline until end of treatment (week 52). ]
    Comparing the octreotide with the control arm.
  • Percentual reduction in oral iron requirement [ Time Frame: From baseline until end of treatment (week 52). ]
    Comparing the octreotide with the control arm.
  • The change in level of serum ferritin [ Time Frame: From baseline until end of treatment visit (week 48). ]
    Comparing the octreotide with the control arm.
  • The percentual decrease in blood and iron infusions. [ Time Frame: The year prior to inclusion compared to the treatment period of one year (week 52). ]
    The percentual decrease in blood and iron infusions between the intervention arm compared to the control group.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2015)
  • Haemoglobin change [ Time Frame: From inclusion in the study until end of treatment visit (week 48) ]
    Change in haemoglobin level comparing the octreotide the placebo arm, as assessed as slope through all haemoglobin measurements taken at study visits during the treatment phase.
  • Number of patients requiring red blood cell transfusions [ Time Frame: From inclusion in the study until end of treatment visit (week 48) ]
    Comparing the octreotide with the placebo arm.
  • The mean difference in hemoglobin level [ Time Frame: From inclusion in the study until end of treatment visit (week 48) ]
    Comparing the octreotide with the placebo arm.
  • Change in number and severity of bleeding episodes [ Time Frame: From inclusion in the study until end of treatment visit (week 48) ]
    Comparing the octreotide with the placebo arm.
  • Number of patients free of rebleeding [ Time Frame: From inclusion in the study until end of treatment visit (week 48) ]
    Comparing the octreotide with the placebo arm.
  • The number and type of adverse events [ Time Frame: From inclusion in the study until last follow-up visit (week 60) ]
    Comparing the octreotide with the placebo arm.
  • Difference in number of hospitalizations, ICU admissions and duration of hospitalization [ Time Frame: From inclusion in the study until end of treatment visit (week 48) ]
    Comparing the octreotide with the placebo arm.
  • Difference in need for rescue therapy [ Time Frame: From inclusion in the study until end of treatment visit (week 48) ]
    Comparing the octreotide with the placebo arm for use of argon plasma coagulation, coiling or surgery.
  • Mortality and cause of death [ Time Frame: From inclusion in the study until last follow-up visit (week 60) ]
    Comparing the octreotide with the placebo arm.
  • Difference in quality of life [ Time Frame: From inclusion in the study until last follow-up visit (week 60) ]
    Quality of Life as measured by SF36 and PSQ-An questionnaire. Comparing the octreotide with the placebo arm.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anaemia Due to Angiodysplasias
Official Title  ICMJE A Multicenter, Randomized, Open-label Clinical Trial Assessing the Efficacy of Octreotide in Decreasing Blood and Iron Requirements in Patients With Refractory Anaemia Due to Angiodysplasias
Brief Summary

The purpose of this study is to determine whether long-acting octreotide is effective in the treatment of patients with refractory anaemia due to angiodysplasias.

The hypothesis is that long-acting octreotide is effective in decreasing the blood and iron infusion requirements in those patients.

Detailed Description

Rationale:

Gastrointestinal angiodysplasias are an important cause of difficult to manage bleeding, especially in older patients. Angiodysplasias are technical challenging to manage endoscopic. Some patients are blood transfusion or iron infusion dependent due to rebleedings despite endoscopic intervention. In clinical practice we face difficulties in these patients as there is no known effective alternative treatment. In small cohort studies octreotide appears to decrease the bleeding episodes in those patients, but the evidence is still to weak to integrate this treatment modality in daily practice.

Objective:

To assess the efficacy of octreotide in decreasing the need for blood transfusions or iron infusion in patients with refractory anaemia due to gastrointestinal bleedings of angiodysplasias despite endoscopic intervention.

Study design:

Multicenter, randomized, open-label intervention study.

Study population:

62 patients, older than 45 years, with refractory anaemia due to bleeding of angiodysplasias without any other possible source of bleeding, who are blood transfusion or iron infusion dependent despite endoscopic intervention and oral iron supplementation.

Intervention:

Patients will be randomized (1:1) into two groups. The intervention group receives Octreotide 40 mg (Sandostatin LAR) once every four weeks for 48 weeks. The control group receives standard of care. The last follow-up visit is in week 60.

Main study parameters/endpoints:

The primary outcome is the percentual decrease in blood and iron requirements between the year prior to inclusion and the treatment period of one year. The percentual decrease will be compared between the intervention and control arm.

Important secondary outcomes are the percent change in the number of rebleeds from baseline to endpoint and the percentage of adverse events. An intention-to-treat analysis will be performed of the outcomes.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Angiodysplasia
  • Vascular Malformations
  • Gastrointestinal Hemorrhage
  • Anemia
Intervention  ICMJE Drug: Octreotide
Two injections of 20 mg will be given monthly.
Other Names:
  • Sandostatin LAR
  • RVG 18236
  • ATC H01CB02
Study Arms  ICMJE
  • Active Comparator: Octreotide
    Drug: Sandostatin LAR Sandostatin LAR 40 mg will be administered once every 4 weeks as a intramuscular injection
    Intervention: Drug: Octreotide
  • No Intervention: Standard of care
    Patients receive standard of care without a placebo.
Publications * Grooteman KV, van Geenen EJ, Drenth JP. Multicentre, open-label, randomised, parallel-group, superiority study to compare the efficacy of octreotide therapy 40 mg monthly versus standard of care in patients with refractory anaemia due to gastrointestinal bleeding from small bowel angiodysplasias: a protocol of the OCEAN trial. BMJ Open. 2016 Sep 12;6(9):e011442. doi: 10.1136/bmjopen-2016-011442.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 9, 2015)
62
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • proven angiodysplasias, without any other possible source of gastrointestinal bleeding.
  • transfusion dependency: at least 4 blood transfusions or iron infusions in the year before inclusion, despite an attempt to supplement iron orally
  • failure of endoscopic therapy: at least one endoscopic attempt to coagulate the angiodysplasias or unsuitable for endoscopic procedures
  • providing informed consent
  • older than 45 years

Exclusion Criteria:

  • age < 45 years
  • liver cirrhosis Child-Pugh C, liver failure or diagnosed portal hypertension
  • previous unsuccessful treatment with octreotide for the same indication (refractory anaemia due to angiodysplasias)
  • current thalidomide treatment which is effective (no transfusion dependency)
  • severe diseases with life expectancy < 1 year
  • patients with left ventricular assist devices (LVAD's)
  • Rendu-Osler-Weber
  • pregnancy or nursing women
  • uncontrolled diabetes as defined by HbA1C >64 mmol/ml, despite adequate therapy
  • hereditary hemorrhagic diseases or haematological disorders with active treatment
  • patients with a known hypersensitivity to SST analogues or any component of the sandostatin LAR formulations
  • symptomatic cholecystolithiasis
  • non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study treatment
  • systemic cancer currently undergoing chemotherapy or radiation therapy
  • refusal to enter the study
  • no understanding of Dutch or English
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02384122
Other Study ID Numbers  ICMJE NLOCEAN.50514.091.14
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radboud University
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE
  • St. Antonius Hospital
  • Jeroen Bosch Ziekenhuis
  • VU University Medical Center
  • Catharina Ziekenhuis Eindhoven
  • Elisabeth-TweeSteden Ziekenhuis
  • Gelre Hospitals
  • Reinier de Graaf Groep
  • Bernhoven Hospital
Investigators  ICMJE
Principal Investigator: Joost Drenth, MD. PhD Radboud University
PRS Account Radboud University
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP