A Chilling Effect

Neurosurgeon studies hypothermia’s healing qualities

by Meredith Raine

Dr. Guy Clifton displays the Rap Round suit, which was invented by UT Medical School researchers.The suit helps keep a patient’s body temperature hypothermic, which helped Julie Gaines make a remarkable recovery from a traumatic brain injury.

Julie Gaines knew better.

There wasn’t an extra helmet, but she got on the back of the motorcycle anyway.

They weren’t going very far, she thought.

It would be OK -- just this once.

When her parents arrived early that morning at Memorial Hermann Hospital, the medical staff described Julie’s condition as grave.

There had been an accident. Julie was thrown more than 100 feet from the motorcycle. Without a helmet to protect her, she suffered massive head trauma.

It was not OK.

Research staff at The University of Texas Medical School at Houston told Julie’s family about an experimental cooling technique pioneered by Guy Clifton, M.D., chairman of the Department of Neurosurgery.

Because of the chilly weather on the night of her accident, Julie’s body temperature was already below normal. In theory, if the medical staff kept her cool for a period of time, rather than allowing her to warm up, the hypothermic state might protect her brain from further damage and possibly aid in her recovery.

Julie’s father, Ron Gaines, a fire marshal for the City of Webster, didn’t hesitate to sign consent forms that would allow Clifton and his team to enroll Julie in the hypothermia study. Gaines knew about people drowning in icy waters, being revived and fully recovering. He figured hypothermia had something to do with that.

“It made absolute sense to me. The cold slows down your metabolism, so your brain doesn’t have to work as much. This helps with the swelling and the healing,” Gaines said. “I understood the concept, and I wanted them to enroll Julie immediately and get started.”

A Long, Cold Road to Discovery

Julie and patients like her are what has kept Dr. Clifton in the arena of brain injury research.

For 15 years, the Runnells Distinguished Chair in Neuroscience has been testing methods in an effort to improve treatment and outcome for patients with severe, closed-head injures.

“One in five clinical trials is positive, so there is only a 20 percent chance of getting right,” Dr. Clifton said. “Drug trials and other studies have failed. Researchers get frustrated, and many have given up because nothing seems to work.”

There have been significant pitfalls in Clifton’s own work. In 2001, one of his multi-center studies disproved preliminary findings that inducing hypothermia could limit major brain damage.

The study was supposed to include 500 patients at nine neurosurgery centers, but it was cut short when analysis of the first 392 patients showed that the hypothermic treatment had no benefit.

Dr. Clifton had hope that the hypothermia would work when nothing else had. It was a huge blow, but he persevered, combing through data, searching for something he may have missed.

What he found were isolated cases where patients did surprisingly well. What was different about these patients? Why did they go on to live independently while others remained in comas or died?

“We kept seeing patients who were doing better than they ought to, and we had no idea why,” Dr. Clifton said. “The devil is in the details. We poured through the data and found some very compelling information.”

The major difference appeared to be that these patients were already hypothermic when they were brought in to the emergency room for treatment. Data showed that if the patients were quickly re-warmed, it was detrimental. But if the hypothermic state was maintained for a period of time, patients seemed to do better -- some remarkably so.

This is was the new direction Dr. Clifton needed. The National Institutes of Health awarded him more than $15 million to begin another multi-center study trial -- this time looking at the effects of prolonged hypothermia rather than its induction. Enrollment began one year ago.

He leads one of the few ongoing clinical trials in the country that is currently studying the treatment of traumatic brain injury.

A Sign of Success

Julie Gaines, a 24-year-old emergency medical technician from Webster, was the first patient nationwide to be enrolled in the study. Because of that, she was automatically assigned to the study group that is kept hypothermic.

Patients that followed have been randomly assigned to either the prolonged hypothermia group or the control group, where they re-warm by themselves, with no medical intervention to raise their body temperature.

Dr. Clifton’s team wrapped Julie in a temperature-controlled suit, which was invented and designed by UT Medical School researchers. The Rap Round suit, manufactured by Gaymar Industries, allowed them to precisely control and maintain Julie’s body temperature at 33-37 degrees Celsius.

Julie’s family watched and prayed. “It was pretty horrendous,” her mother, Beverly Gaines, recalled. “She was all beat up and twitching. They had to shave off her long, beautiful, curly hair. Her nails, which are always perfect, were a mess. They were all torn up.

“There were 17 bags hanging next to her bed, and seven or eight IVs attached to her body,” she said. “This is our baby. We couldn’t even recognize her.”

For the first 48 hours, Dr. Clifton kept Julie cold as part of the research protocol before allowing her body to re-warm naturally.

“The nurses were telling us, `It’s looking grave, but Dr. Clifton said we’re not giving up,’ ” Mrs. Gaines recalled.

For the next 16 days, Julie remained in a coma. Her dad was holding her hand when she awoke. Julie squeezed his hand and mouthed the words, “I love you.” She was back.

Julie remembers getting on the back of the motorcycle and then waking up in the hospital and needing to go to the restroom.

She instinctively got out of bed to make her way to the toilet. When the medical staff forced her back in to bed, she didn’t understand.

She had no idea she almost died in a motorcycle accident. She had no idea that doctors and nurses had told her family that if she survived, she most likely would be in a vegetative state, unable to care for herself.

“I felt fine,” Julie said. “I just wanted to go to the bathroom.”

“I was really supposed to be a vegetable or dead. I went from goner to good.”

Initially, after she woke from the coma, she was weak, sensitive to light and had difficulty remembering conversations with family and friends at her bedside. But that was only temporary.

On Dec. 18, 2002, Julie was discharged from the hospital. Once she made it to the curb in her wheelchair, she walked to the car. She required no rehabilitation, therapy or medication. Her only side effects, oddly, have been itchy skin, and sometimes food just doesn’t taste right.

“The moment I got out of the hospital, I got my nails done,” Julie said.

Her employer made her retake a driving test, and then she was back to work. The only signs of the accident were some road burns on her hands and her unusually short hair. She is now training to be a paramedic and has moved in to her own apartment.

“I was really supposed to be a vegetable or dead,” Julie said. “I went from goner to good.”
Her family credits the hypothermia study for Julie’s remarkable recovery. And Julie jokes that it worked so well for her because she loves cold weather.

“We’ve absolutely seen a miracle,” Mrs. Gaines said. “I don’t think Julie would be her if this research wasn’t being conducted.”

Still Work to be Done

The optimism in Dr. Clifton tells him he’s finally unlocked the mystery of why hypothermia works so well in some brain injury patients. The scientist in him said it’s too soon to tell if he’s finally found a viable treatment, which could help as many as one million Americans who suffer traumatic brain injuries each year.

“Whether it’s chance or victory, I can’t say, but Julie had an unusual recovery,” Dr. Clifton said. “I had gotten her out of the woods, and I figured she would be unconscious when I returned. When I got to her room, she said, `Dr. Clifton, let me give you a hug.’ I couldn’t believe it.”

Dr. Clifton said other patients in the multi-center study also have done well, but much work is yet to be done.

Enrollment has been slow, and Dr. Clifton said it could be at least another two years, maybe even three, before there is enough patient information to prove whether the hypothermia treatment works for brain injury patients who already have lower-than-normal body temperatures when they arrive at the hospital.

“We know a little bit of cooling can be beneficial for the brain,” Dr. Clifton said. “We just have to find the right setting that will produce the best outcome. I predict that within 10 years, we will be paying more attention to patients’ temperatures in all areas of medicine.

”Every time we do a study, we learn a little more,” Dr. Clifton said. “It puts us that much closer to finding the answers. Slowly, we’re making progress. When we see patients like Julie who do so well, it motivates us to continue the research until we figure out what works best.”