Study of Blood Substitute Halted

By TERRI LANGFORD
..c The Associated Press  

HOUSTON (AP) - A test of a blood substitute in emergency room patients has
been halted because more patients died than expected. 

However, tests are continuing with elective surgery patients and with patients
overseas. 

Baxter Healthcare Corp. of Deerfield, Ill., ended the trauma patient test
Tuesday after a review of the first 100 study enrollees showed that people
given the artificial blood HemAssist died at a greater rate than those who did
not receive it, said Mary Thomas, a Baxter spokeswoman. 

The company refused to give the exact number of patients who died among the
100 enrollees. It also would not say how many of the 100 were given HemAssist
and how many were in a control group. 

Ms. Thomas said the company had anticipated that 40 percent of the patients
given HemAssist would die. Instead, she said, the death rate was slightly
above that. 

The race to find a blood substitute has been intense because artificial blood
could ease shortages, eliminate the time-consuming need to match blood types
and wipe out the risk of contamination. In addition, members of some religious
groups refuse to accept transfusions of human blood. 

The study, which originally was slated to include 850 patients, involved
critically injured patients taken to hospital emergency rooms. The decision to
halt the test came as Houston's Ben Taub Hospital was to begin participating
in the trials this week, joining 17 other trauma centers nationwide. 

The discontinued trial was the Phase III testing, usually the last before a
drug is considered for approval by the U.S. Food and Drug Administration. 

No significant problems had been reported in earlier Phase I and II trials
involving more than 1,000 patients. 

In addition, a study of the product in elective surgery patients is continuing
and there are no safety concerns, Ms. Thomas said. 

A study involving severely injured patients in Europe will continue because
there has been no evidence of a higher death rate there. 

Ms. Thomas said experts cannot explain the difference between the U.S. and
European studies, but speculate that differences in the way emergency care is
provided may have influenced the outcome. 

``In Europe, physicians actually ride with the ambulances, and HemAssist is
administered more quickly,'' she said. ``In the United States, patients are
treated after they arrive at the hospital. They have been in shock longer.'' 

AP-NY-04-01-98 1234EST

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