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Anemia and Surgery: Indications For Transfusion

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005308
First received: May 25, 2000
Last updated: February 17, 2016
Last verified: November 2001
  Purpose
To estimate the risk of death for patients with different pre- and post-operative hemoglobin levels who do not receive blood transfusions and to derive a multivariate model using clinical information available pre-operatively that would predict the risk of death post-operatively.

Condition
Blood Disease
Anemia

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 1990
Study Completion Date: March 1995
Detailed Description:

BACKGROUND:

The AIDS epidemic has focused considerable attention on the risks associated with blood transfusions. Perhaps of more importance, hemolytic transfusion reactions and post-transfusion non-A non-B hepatitis continue to be significant concerns. However, guidelines for blood transfusions in the surgical patient vary considerably in the medical literature. Some recent texts stress the need to consider factors such as patient's age, surgical procedure, co-morbid illness, predicted blood loss, and cause of the anemia, as well as the hemoglobin level. Nonetheless, in practice many surgeons still adhere to the 10g/dl threshold for transfusion. The lack of consensus guidelines can probably be attributed to the dearth of studies exploring the indications for transfusion. The few studies which have examined this question are limited because they fail to analyze subsets of patients by age, co-morbid illness, or blood loss. The need to develop peri-operative transfusion guidelines based on multivariate analysis, therefore decreasing the frequency of unnecessary transfusions resulting from the common use of a hemoglobin threshold, is especially important in light of the hazards and costs associated with blood transfusions. Jehovah's Witnesses were chosen as the study population because they decline blood transfusion for religious reasons.

DESIGN NARRATIVE:

The retrospective case-control study explored the possible associations between peri-operative anemia and post-operative mortality status. Cases were defined as those who died within 30 days of the operative procedure and controls as all those who survived. There were approximately eight controls per case. Participating surgeons who operated on Jehovah's Witness patients within the preceeding five years provide a list of patients. Charts of patients were reviewed to determine if any died within 30 days of surgery. If the patient was discharged prior to 30 days postoperatively, then the National Death Index was used to assess the patient's status 30 days after surgery. The incidence of post-operative death, with 95 percent confidence levels, was calculated for strata of pre- and post-operative hemoglobin levels and operative blood loss. The death rate was calculated after stratifying the patients based on status with regard to co-morbid diseases or other possible risk factors.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

  Eligibility

Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00005308     History of Changes
Other Study ID Numbers: 3011  R01HL041523 
Study First Received: May 25, 2000
Last Updated: February 17, 2016
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on December 06, 2016