Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00005308 |
| Other study ID # |
3011 |
| Secondary ID |
R01HL041523 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 25, 2000 |
| Last updated |
February 17, 2016 |
| Start date |
April 1990 |
| Est. completion date |
March 1995 |
Study information
| Verified date |
November 2001 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical 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.
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.
