Tuesday, January 15, 2013

The blue pill - 9

(This is the ninth part of the short story The Blue Pill. You can find the entire story here.)

The next set of tests were critical. Most people on dialysis undergo sessions thrice a week, for four hours each time. Short duration dialysis proved only that the device was as good as regular dialysis. This was what was achieved in the first set of tests. That was obviously not what this was all about. Well, by adding flexibility to the patients’ lives, you were making a difference. However, this was not as important as adding years to their lives. This was what the device was capable of achieving. That was the whole point of the device.

Dr. Roy was fairly assured of the results however. This had been tried in his lab in the past. For single patients only. However, the concept remained the same.

The next morning, the team spread out to the various centers and began preparations for the nocturnal tests. They would all stay awake during the entire night monitoring the lines and making sure nothing went wrong. Dr. Roy took an afternoon nap. He wanted to make sure he was alert to take care of anything unexpected that may arise.

All the patients were connected to the device by around 8:45 p.m. The blood samples collected before beginning were all sent off to the lab. Dr. Roy was in touch with all the centers over phone. Everything seemed to be ok.

About three hours into the sessions, Dr. Roy got a call from one of the centers. One patient’s blood started clotting in the device. They tried controlling it with some saline. However, it did not help. Within minutes, he got a call from another center. The same problem. Blood started clotting in the device. Within the next half-hour or so, every single center reported the blood clotting issue from most patients. 

The control team was dumbstruck. Dr. Roy was shocked. He couldn’t believe what was happening. They had an emergency meeting where they reviewed all the treatment parameters. They carefully reviewed the anti-coagulation protocol being followed. Everything seemed to be in place. They were using heparin which was a widely used anti-coagulant. People had been using heparin for regular nocturnal dialysis for years now. What could be wrong?

No one had any ideas. They had to take a decision soon. Time was running out. They decided to pull the plug. Instructions were passed to all centers to stop the dialysis sessions for all patients. Everyone was disappointed. Dr. Roy was devastated. He was sweating profusely. The team urged him to relax saying they would soon figure out the problem. Someone offered him a glass of cold water. What could have gone wrong? They all wondered.

The entire team returned to the Babylon lab from where the control team monitored the trial. They were all discussing what had just happened. Dr. Roy than asked all of them to come to the meeting room. He had calmed down by then. No need to panic. They had obviously missed something. Let us look at this systematically. One piece at a time. We will soon figure it out.

One by one, he collected the exact sequence of events at each center. It all seemed to follow a pattern. The first couple of hours went smoothly. After about two and half hours, one by one, the clotting started. Nothing they tried would help. There was something really wrong. They had used the standard anti-coagulant. What could have caused the clotting?

Dr. Roy called it a night and asked the entire team to go home and return the next day when the future course of action would be decided.

The next morning, Dr. Roy first met with Karl Torrance. Dr. Roy suggested they scrap the trial and start from scratch. Torrance wanted to investigate and try and fix the problem before the next scheduled session. They would have two full days and a night before starting the sessions. Dr. Roy felt they couldn’t put the patients at risk. Already many of them had lost a lot of blood because of the clotting. Torrance relented in the end.

Dr. Roy met his team at the control room. He announced that the trial was being scrapped.

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