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Blood DiseaseNCT00005308

Anemia and Surgery: Indications For Transfusion

An observational study of Blood Disease and Anemia, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages Up to 100 years, men only
Conditions the study is for
Blood Disease, Anemia
How many people
Not given
Where
No sites listed yet
Study dates
Apr 1990to Mar 1995
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 100 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

No eligibility criteria

About this study

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.

Read the 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.

Medical subject headings
Hematologic Diseases, Anemia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2000 (estimated)
  2. Study startApr 1990
  3. Study completionMar 1995

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005308
Sponsor's protocol ID
3011
Other IDs
R01HL041523
Status last verified
Nov 2001
First submitted
25 May 2000
Last updated
18 Feb 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Blood Disease and Anemia, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.

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